Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum in Patients Age 40 and Older
Phase: NA
Conditions: Acetabular Labrum Tear, Femoro Acetabular Impingement, Hip Arthroscopy, Physical Therapy, Osteoarthritis, Hip
Sponsor: Massachusetts General Hospital

ClinicalTrials.Gov Cover Page 
 
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum 
 
NCT: NCT03909178 
 
Date of Latest IRB Continuing Review: 2/5/2021 
 

 
Version: 4.0   Date: 08/20/19  
 
 
 
 
 
 
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DETAILED PROTOCOL 
 
Title: Arthroscopic Labral Repair versus Physical Therapy for Tears of the Acetabular Labrum in 
Patients Age 40 and Older 
 
I. 
BACKGROUND & SIGNIFICANCE: 
 
Introduction 
 
Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears 
in the general population approaching 66% and 70% based on cadaveric dissection and magnetic 
resonance imaging, respectively.1, 2 Despite this prevalence, there is no currently accepted justification for 
performing labral repair in an asymptomatic patient despite the many postulated biomechanical benefits 
that an intact labrum imparts to the hip joint.3-6  
Representing a smaller proportion of all tears, symptomatic tears of the acetabular labrum 
present a therapeutic challenge. Current treatment modalities range from conservative measures to open 
surgical intervention. Conservative measures have typically included: activity modification, the use of non-
steroidal anti-inflammatory drugs (NSAIDs), physical therapy (PT), core strengthening and improvement 
of sensory motor control.7 In the past two decades, technological advances in the form of surgical 
instrumentation and traction devices have facilitated less invasive arthroscopic techniques to diagnose 
and treat hip problems and as such is now the preferred treatment modality for many orthopedic surgeons 
treating patients with hip pathology.8-10  
Femoroacetabular Impingement (FAI) is a common cause of acetabular labral pathology. Over 
the past decade hip arthroscopy has become the established modality for treating this entity.11-13 
However, despite the widespread utilization of hip arthroscopy there is a paucity of evidence to validate 
the use of this procedure over conservative management or other forms of open surgery.14 Several 
authors have suggested that while initial studies on the utilization of hip arthroscopy are promising, the 
current evidence base is lacking.15 In particular there is a lack of high quality evidence evaluating 
outcomes for non-operative management of labral pathology.  
Physical Therapy 
 
There are only a few reports recommending the routine use of physical therapy in patients with 
tears of the acetabular labrum.11,16  In particular, it has been emphasized that physical therapy should 
focus on improving strength resulting in fewer forces directed on the anterior portion of the hip, the site 
most commonly afflicted by labral tears17,18.  Accordingly, there are just as few reports comparing the 
efficacy of physical therapy versus arthroscopic intervention for management of labral tears. 
Two level IV cases series report evidence on the results of conservative management of 
acetabular labral pathology. Emara et al.19 report 2-year follow-up data on 37 patients with FAI followed 
prospectively. These patients were found to have improved hip outcome scores but with much limited 
activities of daily living and non-improvement in hip motion. Here conservative therapy was defined as 
intensive physiotherapy, stretching, assessment of range of motion, and determination of problematic 
motion that patients were advised to avoid. Yazbek et al.20 report on the non-surgical management of four 
patients with clinical evidence and magnetic resonance imaging confirmation of an acetabular labrum 
tear. These patients were managed with NSAIDs for pain control and multiphase physical therapy 
focusing on improving strength and range of motion. All four patients demonstrated decreased pain as 
well as functional improvements over a 6-month follow-up period. The authors concluded that patients 
with clinical evidence of acetabular labral tears could show meaningful improvement with non-surgical 
intervention.  

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There has been only one prospective study documenting the outcomes of patients treated with 
physical therapy for intra-articular conditions of the hip.21 These conditions included mild FAI and mild 
developmental dysplasia of the hip.  Here, physical therapy was given as a first line treatment.  Those 
who did not make satisfactory improvements in pain or wished to have surgery were then scheduled for 
surgery to repair the defects.  Patients saw improvement in validated outcome measures at one year.  
The authors attempted to eliminate cases of advanced arthritis based on Tonnis grading (see section IV) 
scores greater than 2.  However, there was no mention of the degree arthritis seen at the time of 
arthroscopy and the presence of a labral tear due to the aforementioned pathology was not part of the 
inclusion criteria, rather it was a secondary data point. 
 
Arthritis 
 
Symptomatic, radiographic osteoarthritis (OA) affects over 27 million people in the United States; 
of this number, a significant proportion are affected by OA in the hip.22  Additionally, it is well known that 
older patients presenting with symptomatic labral tears are more likely to have OA. In fact, it is estimated 
that 25% of the general adult population has some type of cartilage defect.2 Despite its prevalence the 
influence of preoperative arthritic changes on surgical outcomes is controversial. A recent systematic 
review gave a grade Cc recommendation for hip arthroscopy for the treatment of mild to moderate hip 
arthritis (conflicting).14 Another systematic review concluded that although some benefit is achieved in 
arthritic patients, the presence of cartilage defects at the time of surgery results in poorer outcomes than 
cases with normal cartilage.23 There is an abundance of discussion in the literature with a specific focus 
on the influence of pre-existing arthritis on hip arthroscopy outcomes.24-33 In order to highlight this 
influence, one group created a Kaplan-Meier survival analysis that showed a high rate of conversion to 
total hip replacement in patients aged over 50 years old, and within this cohort, patients with less than 2 
mm of joint space (radiographic OA) were found to have an increased failure rate.32  
The distinction between radiographic arthritis and arthroscopically (directly visualized) identified 
arthritis is important.  Several radiologic-surgical correlation studies34-36 in the knee have shown that direct 
visualization of joint tissues by arthroscopy is more accurate in diagnosing cartilage loss and meniscal 
damage, making an arthroscopic exam the gold standard of investigation before definitive treatment 
planning in the knee.36 This standard has not yet been achieved in the hip. 
A retrospective evaluation of arthroscopically identified arthritis and its influence on outcomes in 
patients undergoing periacetabular osteotomy, not primary arthroscopic labral repair, has been 
reported.37 This study involving 121 patients was able to show that exposed subchondral bone 
(Outerbridge grade 4 change; see section IV) was predictive of accelerated conversion to total hip 
arthroplasty.  Secondarily, it was postulated that standard radiographs of the hip are poor predictors of 
actual arthritic lesions due to the amount of arthritic change that was noted at arthroscopy in patients 
whose preoperative radiographs showed minimal evidence of OA. Furthermore, there has been only a 
single prospective study evaluating the influence of the degree of arthroscopically identified arthritis, using 
the Outerbridge scoring system, on validated patient outcomes following repair of a torn acetabular 
labrum.  The results of this study involving 50 patients showed a negative correlation between the 
severity of arthritis and improved outcomes, drawing the conclusion that patient outcomes are directly 
influenced the presence and degree of arthritis.38 Setting up the argument that direct visualization of the 
articular surfaces in the hip should be the gold standard for identification of arthritis, just as it is in the 
knee.  However, before attempting to reach such a conclusion, the effects of cartilage defects on the 
progression of OA symptomatology in the hip needs to be further elucidated. Specifically, no evaluation to 
date has been conducted that specifically addresses size and location of osteochrondral defects and the 
effect these defects have on OA progression in the hip following repair of a torn acetabular labrum. 

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Age 
Very little formal investigation has been performed to study the influence of age on hip 
arthroscopy outcomes; as such, there is currently no consensus on age as a predictor of outcome. 
Khanduja and Villar12 recommend arthroscopy to be reserved for patients aged less than 50 years old. 
Philippon et al.32 reported outcomes after FAI in patients aged 50 years or older at a minimum 1-year 
follow-up and found that patients primarily achieved surgical success, though with a 20% conversion to 
total hip replacement (with a higher incidence in patients with > 2 mm of joint space). Larson et al.24 also 
showed a failure rate that was dependent on age; however, a formal comparison was not made. Byrd and 
Jones39 showed worse outcomes in older men. Although there have been studies looking at age 
secondarily in patients with labral tears, there is no prospective evidence to endorse or refute a 
recommendation of hip arthroscopy for patients of any age being treated for a tear of the acetabular 
labrum.  
 
Preliminary Data 
Our group recently performed a large retrospective case-control series looking at the influence of 
pre-operative arthritis and age as predictors of long-term outcomes following arthroscopic labral repair.40 
Over the course of the study period, which spanned 8 years and 200 patients, our management evolved 
to reflect the current practice of abstaining from arthroscopy in patients with less than 2 mm of joint space 
on plain standing radiographs. In spite of this, we continue to routinely encounter cartilage defects intra-
operatively. Such findings can be explained by evidence stating conventional radiographic measures are 
poor predictors of actual arthritis in the hip.48 Although it is possible that focal cartilage defects seen at 
arthroscopy are incidental findings.42 
Most studies attempt to eliminate radiographically evident severe arthritis by excluding patients 
who demonstrate less than 2 mm of joint space on standing antero-posterior hip radiographs at the time 
of surgery. However, based on our results, we suggest that the presence of Outerbridge grade 4 arthritic 
changes noted at the time of arthroscopy can be used adjunctively to identify patients who will fare poorly 
after hip arthroscopy for labral pathology. Interestingly, despite the apparent influence of arthroscopically 
identified arthritis portending worse outcomes (Odds ratio=2.5), our preliminary results suggest age is a 
stronger predictor (Odds ratio = 7) of diminished surgical outcomes.  
Most recently, the authors involved in this study performed a retrospective investigation 
(unpublished data) to capture patients with clinically and radiographically confirmed acetabular labral 
pathology electing to undergo conservative management defined as the refusal of surgical intervention. 
Based on a retrospective review of 894 patients presenting to clinic over a 10-year period, we identified 
22 patients with labral pathology that were treated non-operatively. Retrospective case control analysis 
was performed using outcome questionnaires administered to both surgical and non-surgical cohorts. We 
found that patients with labral tears managed non-operatively appear to score highly on hip function 
outcome scores, preliminarily indicating there may be some benefit in using conservative management 
alone in the treatment of labral pathology. Controlled comparative analyses between surgically and non-
surgically managed patients suggested that non-operatively managed patients exhibit a non-significant 
tendency toward worse outcome. 
Given the lack of current guidance for judicious use of hip arthroscopy for labral pathology in 
patients of increasing age with arthritic change, we propose that there is a need for high quality 
prospective comparative studies assessing hip arthroscopy against physical therapy as a non-operative 
form of management for tears of the acetabular labrum. Furthermore, preliminary evidence by our group 
and the published data of others described above highlights the necessity for continued investigation into 

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this topic with particular emphasis on the role of preexisting arthritic change in this select group of 
patients. Without prospective investigation into the role of arthritic burden and age, we cannot begin to 
fully assess their influence on outcomes following labral repair. 
 
Implications: 
 
Determining which patients, using age and arthritic burden as predictors, can benefit from labral 
repair is paramount for several reasons.  Showing arthroscopic repair is of little or no benefit to a specific 
cohort can reduce the number of unnecessary surgeries performed, increase the use of conservative 
therapy (if validated) and reduce the interval between diagnosis and total hip replacement.  Additionally, 
proving a benefit exists from arthroscopic repair in a certain subset of the population will substantiate the 
need for developing a treatment algorithm in older patients presenting with labral tears and some degree 
of pre-existing arthritis.  Furthermore, conservative physical therapy may prove to be of equal or greater 
benefit than arthroscopic repair in select patients. If true, this study will be a landmark for providing the 
evidence needed to recommend conservative treatment as an efficacious alternative in addition to 
providing a foundation for future research on this topic. 
 
II. SPECIFIC AIMS: 
Specific Aim 1:  To evaluate if physical therapy alone or arthroscopic labral repair and physical therapy is 
of greater benefit to patients presenting at age 40 with tears of the acetabular labrum.  
 
Hypothesis 1.1: Physical therapy will result in a significant difference in mHHS scoring at 12 
months when compared to baseline. 
Hypothesis 1.2: Arthroscopic labral repair will result in a significant difference in mHHS scoring at 
12 months when compared to baseline. 
Hypothesis 1.3: Arthroscopic labral repair and physical therapy will be superior to physical 
therapy alone in improving function and alleviating symptoms at 12 months when compared to baseline, 
as judged by the mHHS. 
Hypothesis 1.4: Hypotheses 1.1-1.3 will hold true at 24 months and beyond. 
Hypothesis 1.5: Functional outcome scores collected at the completion of PT will not significantly 
differ from those collected at 12 and 24 months and beyond in the same group. 
 
Specific Aim 2:  To evaluate the effect of arthritic burden on short term outcomes following arthroscopic 
labral repair. 
 
Hypothesis 2.1:  In the surgical treatment group, subjects with arthroscopically proven severe 
osteoarthritis (Outerbridge grade 4) will do more poorly on validated outcome measures, specifically the 
mHHS, after arthroscopy than subjects with less severe osteoarthritis (Outerbridge grade  3).  
Hypothesis 2.2: Cartilage defects at or near the chondrolabral junction are prognostic indicators 
of worse outcomes as determined by the mHHS. 
Hypothesis 2.3: Subjects with any degree of joint space narrowing (classified by Tonnis and 
Kellgren-Lawrence grading, see below) on plain radiographs will have more pain, regain less function, 
and do more poorly based on validated outcome measures, specifically the mHHS, at 6 and 12 months 
than subjects without any degree of joint space narrowing on plain radiographs. 
 
EXPLORATORY Specific Aim 3:  To evaluate the relationship between joint space narrowing on plain 
radiography and arthroscopically proven osteoarthritis. 
 

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Hypothesis 3.1: Tonnis grading and Kellgren-Lawrence grading on plain radiography are not 
predictive of the severity of arthritis at the time of arthroscopy. 
 
Specific Aim 4: To analyze the data of subjects crossing over from PT alone to PT and surgery. 
 
 
 
Hypothesis 4.1: Primary outcome scoring (mHHS) at 12 and 24 months after cross to surgery and 
PT will differ significantly from those initially randomized to surgical treatment. 
 
Hypothesis 4.2: Baseline scores on outcome measures of those subjects crossing over will not 
differ significantly from those obtained at the time of crossover. 
 
 
 
III. SUBJECT SELECTION & ENROLLMENT: 
 
Study Overview:  This is a prospective randomized control trial (RCT), which will enroll subjects with a 
clinically diagnosed tear of the acetabular labrum. Subjects who have been diagnosed with a labral tear in 
clinic will receive conservative physical therapy treatment alone or arthroscopic surgical labral repair and 
physical therapy. If it is discovered that there is unexpected pathology at the time of arthroscopy for 
subjects in the surgery group, those subjects will be removed from the study. This is due to the possibility 
that the source of pain is less likely a result of the dysfunction of the labrum and more likely due to 
aberrant extra-articular biology. We will use validated outcomes measures that include the mHHS, LEFS, 
HOS, NAHS, and iHOT-33 (see below) and review the medical record for physical exam findings to track 
patient progress throughout their involvement in the study which will continue for as long as they are a 
patient of the PI. Study procedures will be complete when the last enrolled subject completes 24-month 
follow-up and completes the corresponding surveys. 
Our Primary Outcome is change in the modified Harris Hip Score at 12 months and 24 months.  
Secondary outcomes include changes in other validated outcomes measures  patient satisfaction, and 
degree of improvement on physical exam. The influence of OA severity (Outerbridge scoring) and 
location of OA will also be analyzed to determine if they have an effect on the aforementioned outcome 
measures. Satisfaction will be assessed by an exit questionnaire (See section IV).  In addition to gauging 
satisfaction, this questionnaire will ask subjects how they felt about their participation in the study.  (See 
section IV) 
 
Inclusion and Exclusion Criteria: 
 
Inclusion criteria 
Rationale 
Age 40 or greater 
Higher likelihood of undetectable OA on imaging 
 
 
Orthopedic surgeon determines symptoms are 
consistent with a labral tear. 
Required for treatment  
Availability of hip radiographs and MRI  
Needed to assess eligibility and comparison for 
specific aim 3 
 
 
Willingness to undergo randomization and ability to 
understand and sign informed consent document 
 
Ability to understand study and consent willingly 

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Exclusion criteria 
Rationale 
 
 
Unexpected pathology at the time of arthroscopy 
Source of pain less likely to due dysfunction of the 
labrum and more likely due to aberrant extra-
articular biology 
Same site surgery 
Complex anatomy 
 
 
Contraindication to surgery or physical therapy 
Cannot tolerate either treatment grouping 
 
Alternate form of PT for greater than 6 weeks 
 
Will negatively augment results. May affect 
recruitment. 
 
Selection and enrollment: 
We will enroll 122 consecutive subjects meeting the aforementioned criteria. Subjects will be 
randomized into conservative or surgical treatment arms. All potential subjects on the clinic schedule of 
the investigator will be pre-screened for eligibility based on age, clinical assessment, and previous 
medical history. 
All eligible subjects will be approached at an outpatient clinic visit.  Those who initially meet 
inclusion criteria will be introduced to the study and given a research consent form that they have the 
opportunity to take home and to review.  
The research coordinator will randomize the subjects into the study at this visit. Randomization 
will be assigned utilizing an electronic randomization program. Those receiving conservative 
management will be scheduled for physical therapy.  Those receiving surgical management will be 
scheduled for surgery and the post-operative physical therapy protocol within 2 weeks of their operative 
date. 
Efforts will be made to attain a mix of study participants, regarding gender and racial/ethnic 
representation reflective of the population of the greater metropolitan Boston area: 66% White, 14% 
African American and 10% Hispanic or Latino. More specifically, we anticipate that at least half of our 
subjects will be female and that we will have representation from Asian American, African American and 
Hispanic minority groups in our final cohorts.  
 
Informed consent:   
The informed consent document will be approved by the IRB at Partners HealthCare, which 
covers The Brigham and Women’s Hospital, Faulkner Hospital, and the Brigham and Women’s/Mass 
General Health Care Center at Foxborough. The informed consent process will be conducted by the PI.  
 
 
Overview of sample size:   
This randomized control trial includes 122 subjects age 40 or older with evidence consistent with 
tears of the acetabular labrum in the affected hip 
Meeting recruitment targets:  
As previously mentioned, the design of our study is similar to that of the MeTeOR trial 43 in which 
Dr. Martin and Dr. Safran-Norton were lead investigators.  Dr. Martin was the highest referral base for the 

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MeTeOR subjects at the BWH site and Dr. Safran-Norton designed, delivered and managed the physical 
therapy protocol for both arms of the MeTeOR trial across 7 national trial centers.  Based on a survey 
before that trial commenced, it was estimated that 20-25% of eligible subjects would agree to participate 
in the randomized controlled trial. Participation in the actual trial was 26%. We anticipate a similar 
recruitment percentage as our design is similar as are our inclusion criteria. 
 
 
Study retention procedures: 
Dr. Martin and Dr. Safran-Norton were investigators in a similarly designed multicenter trial 
involving meniscal tears in the knee.43 In that recently published study, once enrolled, the patient 
retention rate was approximately 90%. We believe we will have similar success over the course of this 
study. Nevertheless, procedures will be in place to aid in maintaining subject participation over the course 
of the study.  Outcome measures collected around formal visits can be collected remotely. Subjects can 
receive the surveys via email sent through REDcap. Study staff will conduct reminder phone calls around 
data collection time points.  
 
 
 
 
IV. STUDY PROCEDURES: 
 
Enrolled subjects will complete surveys around normal clinic visit intervals. Subjects will continue 
receiving surveys around their normal postoperative clinic visits until they request to stop receiving them. 
We are interested in long-term outcomes for these treatment arms, so we hope to collect patient-reported 
outcome measures for several years after randomization. These surveys can be completed remotely or at 
clinic visits. Follow up/reminder calls will be conducted to ensure subjects complete surveys.   
 
 
Medical History: 
 
The medical record may be reviewed for relevant medical history, imaging, physical exam, and 
surgical procedure from the subject’s operative note, imaging, or clinic visit notes.  
 
 
Patient-Reported Outcome Measures (PROMs) Surveys:  
Pain/Physical Function: 
 
Modified Harris Hip Score (mHHS): The MHHS is a validated condition specific outcome instrument that is 
used widely after hip arthroscopy. The eight questions measure domains of pain, gait function, and 
functional activities. Scores range from 0 (poor) to 100.1 (ideal).45,46 
 
The Lower Extremity Function Scale (LEFS): The LEFS is a 20 item validated outcome measure that is 
commonly used by physical therapists to initially evaluate and subsequently monitor patient progress 
through the course of a rehabilitation program.  The minimum level of detectable change is 9 points.47 
 
Hip Outcome Score (HOS):  The HOS is composed of the activities of daily living (HOS-ADL) subscale 
and the sports (HOS-sports) subscale. The HOS-ADL subscale contains 19 items pertaining to basic daily 
activities, and the HOS-sports subscale contains 9 items pertaining to higher-level activities, such as 
those required in athletics. In addition to the 5 potential responses, ranging from “unable to do” to “no 

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difficulty,” a response of “not applicable” is an option to allow subjects to designate that something other 
than their hip problem limits their activity. Use of the HOS is supported for individuals with labral tears. 
Importantly, this includes individuals who underwent arthroscopic surgery, as well as those who did not.48 
A score change beyond 3 points represents a change beyond measurement error for the HOS-ADL and 
HOS-sports subscales. An increase in the score above 9 points and 6 points represents a meaningful 
increase for the HOS-ADL and HOS-sports subscales, respectively.49 
 
The Nonarthirtic Hip Score (NAHS): The NAHS is a validated, self-administered 20-item questionnaire 
designed to assess non-arthritic hip pain in patients with high activity demands and expectations.50 
 
International Hip Outcome Tool-33 (iHOT-33):  Measure health related quality of life. The iHOT-33 
includes 33 questions or items, each answered by marking a visual analog scale between 2 anchor 
statements. This can be done on a paper form (with a 100-mm scale) or as part of a computer-based 
system. The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 
100 representing the best possible quality-of-life score. It is most suited for research purposes.51 
 
Psychiatric/Psychological Measures:  
 
Short Form 36 (SF-36): The SF-36 is a self-administered questionnaire consisting of 36 items, requiring 
5-10 minutes to complete. The 36 items generate a profile of scores across eight dimensions of 
health: physical functioning (10 questions), social functioning (two questions), role limitations 
(physical problems) (four questions), role limitation (emotional problems) (three questions), mental health 
(five questions), vitality (four questions), pain (two questions), general health (five questions). One 
question addressing health change (transition) is not scored nor represented in the eight dimensions.53 
SF-36 appears to be a valid instrument, responsive to changes in health status over time among 
unintentionally injured adult people. Thus it may be possible to use the SF-36 to describe changes in 
health due to injury. The applicability of this or similar measures for injured children remains to be 
established.54 
 
Exit Questionnaires: 
 
Patient Satisfaction:  This questionnaire will be disseminated to subjects yearly starting around the time of 
their 1-year follow up clinic visit and yearly thereafter.  The questionnaire will contain 3 items.  The 
purpose is to gauge how satisfied with each subject is with 1) their specific treatment regimen during the 
study 2) their outcomes of their specific therapy and 3) if given the choice, would the subject undergo the 
same therapeutic regimen. (See addendum) 
 
Participation questionnaire: This 6-item questionnaire was designed to assess how patients felt about 
their care during the study, if they would participate in a similar study, how well they feel the outcomes 
measures addressed their hip condition, and what factors, if any, would increase participation in a future 
study. (See addendum) 
 
Study compliance monitoring, treatment credibility assessment, and data management:   
Subjects will be given contact information for the IRB and study coordinator. Subjects will also be 
seen in clinic. In addition to regular clinical follow-up the purpose of these interactions is to identify 
adverse events, patient concerns, and to check on patient compliance with physical therapy regimen, 
which is particularly important over the first 3 months.  At the end of the trial all subjects will complete an 

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exit questionnaire. All data is collected with RedCap electronic software, which reports on missing data 
and data outliers.  We can also then quantify and analyze treatment compliance.   
 
PHYSICAL THERAPY VISITS 
 
Please see attachments for post-operative and non-operative physical therapy protocols as well 
as advancement criteria. 
 
The physical therapy protocol was developed by an experienced board-certified physical therapist 
utilizing nationally recognized surgical post-op hip labral repair protocols in addition to an extensive 
literature review for best practice in treating patients with labral tears.  The physical therapy protocol was 
specifically designed to be similar in both arms of the study with consideration for differences in those 
patients post-op.  The intervention was designed to be a rigorous program that allows for individualization 
for patients with specific impairment and functional limitations yet standardized with specific guidelines for 
best practice.  The three-stage structured program is designed to address inflammation, pain, range of 
motion, muscle strengthening, muscle length restrictions, aerobic conditioning (e.g. bicycle, elliptical, 
treadmill), functional mobility, proprioceptive/balance training.  The program additionally recognizes and 
considers adjacent joints associated with hip pain e.g. lumbar spine, pelvic girdle and hip.  The specific 
content of the PT program is outlined in a separate document.  The three phases of intervention include:  
Acute Phase I with a focus on ROM, pain and edema, Sub-acute Phase II which introduces muscle 
reeducation and Phase III which addressed more advanced muscle strengthening, balance, 
proprioception and higher level functional mobility.  Criteria for advancing from Stages I to II and II to III 
include the level of self-reported pain, observed strength, range of knee motion, knee effusion soft tissue 
restrictions, pelvic alignment symmetries and functional mobility.  In each stage, the patient is 
recommended to attend 1-2 PT sessions up until 12 weeks depending upon physical therapy examination 
findings. The patient will also have an individualized home exercise program. Patients will use their 
regular health care insurance for these treatments, which is considered standard practice.  The protocol is 
designed to accommodate the various types of insurances for all patients.  The physical therapy 
documentation will be kept in a secure electronic medical record.  The study physical therapists are not 
blinded to the study as they are treating every patient in the trial.  Dr. Safran-Norton will train and assure 
competencies for each study physical therapist.   
In order to objectively track each individual subject’s progress enrolled in the PT alone group, we 
employ the use of “advancement criteria”.  These criteria will serve as a safety and quality control 
measure.  Failure to meet these advancement criteria is a trigger for re-referral back to the orthopedic 
surgeon for potential cross over due to an inadequate response to PT.  Non-achievement of the 
advancement criteria outlined for each phase of the physical therapy protocol is a cause for clinical 
concern that the PT intervention has been ineffective or not effective enough.  We plan to use these 
advancement criteria for those subjects enrolled in the physical therapy alone arm of this randomized 
controlled trial as an objective measure to monitor subject progress and safety.   At each treatment 
session, which will ideally take place every third day (1-2x/week) once enrolled, subjects will undergo 
complete evaluation by the physical therapist for clinical concern that the subject is not adequately 
responding to PT (page of the detailed protocol).  Therefore, each subject who is compliant with the non-
operative PT protocol will undergo formal evaluation at least once per week during the course of 
treatment.  This is exactly what would be done in normal routine practice and our study procedures will 
not deviate from this. Progression through the advancement criteria will be documented in the subjects 
chart on a separate sheet of paper (attached) requiring the dating and signature of the physical therapist 
for advancement through the protocol or re-referral back to the surgeon, which is considered standard of 
care and common practice. 

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In addition, subjects can subjectively withdraw from PT any time point if they feel that it is not 
working for them the way they would like.  However, in order to standardize the amount of time that 
lapses between enrollment and potential cross-over, subjects wishing to transition to surgical treatment 
cannot do so until 6 weeks after initial enrollment (see figure 5 of the study schema).  There are several 
reasons for this: First, we want subjects to have enough time to see the benefits of PT, as they may not 
be immediate.  Second, if the decision to cross over is made prior to 6 weeks, the remaining time allows 
for scheduling of a follow-up appointment in a timely manner that does not delay appropriate patient care. 
Lastly, subjects are not required to continue under the PT protocol, they can stop at any point and not 
receive further PT or medically directed care until their follow-up.  This scenario is no different than if a 
patient, in a non-study setting, self discontinued a recommended course of PT and sought surgical 
consultation elsewhere.  The advantage here is that subjects will already be known to both the hospital 
system and surgeon, which allows for quicker consultation. 
 
SURGERY 
While randomization is a research procedure for this study, the surgery itself is not a research procedure. 
This surgery is standard of care for patients with symptomatic labral tears, and the PI regularly performs 
labral repair in patients not enrolled in research. 
 
 
POSTOPERATIVE PROTOCOL 
 
All procedures are performed on an outpatient basis. Patients are allowed flat-foot full weight 
bearing immediately postoperatively. Patients are instructed in gait training, keeping a level pelvis and 
avoiding any lurching of their pelvis during ambulation. Patients are kept weight bearing as tolerated with 
crutches for 6 weeks postoperatively for a labral repair. Patients are allowed full active range of motion as 
tolerated immediately with avoidance of deep squatting and impact loading exercises for 4 months 
postoperatively.  This is considered standard practice. 
 
V. BIOSTATISTICAL ANALYSIS 
 
Hypothesis 1.1-1.4: 
 
The mean outcome scores of the mHHS in each treatment group at 12 months will be compared 
to baseline scores to assess for significant differences using paired sample t-test in SPSS 16 (SPSS, 
Chicago, IL).  The mean outcomes scores of the mHHS between groups at 12 months will be compared 
using independent t-tests to assess for significant difference.  We will use a Levene test to judge variance 
and proceed accordingly. If a statistically significant difference is detected during these analyses, we will 
calculate the effect size (ES) to determine how meaningful these results are outside of being statistically 
significant. The ES will be calculated by: [(mean mHHS score of surgical arm / mean mHHS of the 
conservative group) / standard deviation of the conservative group]. According to Cohen 58, an ES <0.1 is 
trivial, ES of 0.1-0.3 is minimal, ES of 0.3-0.5, is moderate, and ES >0.5 is large.  We will repeat the same 
analysis at 12 months. 
 
Hypothesis 2.1, 2.2, and 2.3: 
Diagnosis and treatment of the prearthritic and early arthritic hip has been an area on intense 
interest.  However, our most conventional method of assessment (plain radiography) does not provide us 
with enough diagnostic sensitivity.41 Direct visualization on the articular surfaces in the hip is both 
sensitive and specific. Furthermore, emphasis is being placed on the location of arthritis as a prognostic 
indicator of good outcomes following hip arthroscopy.  The value of arthroscopic techniques for primary 

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symptoms and/or prevention of OA secondary to labral tears remains unclear even though preliminary 
reports indicate there may be some benefit to repairing a torn labrum, even in cases of severe OA. 
Evaluation of arthritic change at the time of arthroscopy is important, particularly in subjects where there 
remains uncertainty about the efficacy of labral repair for those with articular or rim cartilage degeneration 
that the effects of those changes on long-term OA progression.59 
We plan to track the effects of OA on outcomes through identification and localization of OA at 
the time of arthroscopy using a mapping technique (see diagram). After complete visualization of the 
intra-articular space, as is standard practice in hip arthroscopy, classification of any existing osteoarthritis 
will be done according to the Outerbridge grading scale.  Using this system, we are able to categorically 
group subjects based on location and severity of disease. If multiple lesions are present, subjects will be 
characterized by the most severe grade.  Furthermore, based on the data gathered through meeting 
hypotheses 1.1-1.4, we will subdivide primary outcome scores into four categories.60 Category I, excellent 
outcomes (mHHS 90); Category II, good outcomes (mHHS 80); Category III, fair outcomes 
(mHHS70), and Category IV, poor outcomes (mHHS <70). The likelihood of outcomes based on 
Outerbridge grading and outcome category will be determined through odds ratios. Analysis will be 
carried out using Chi-squared tests. Significance is set at P<0.05.  Linear regression analysis will be 
performed to detect if any relationship exists between the severity of osteoarthritis and short-term 
outcome scoring. 
 
Hypothesis 3.1: 
 
This is an exploratory hypothesis whose assessment will no influence the other data sets. Prior 
work by other groups has demonstrated that evaluation of arthritic burden by conventional measures 
(Kellgren-Lawrence and Tonnis grading) are not indicative of the severity of arthritis found at the time of 
arthroscopy.58  We will explore this phenomenon in our own cohort of subjects, specifically those in the 
surgical group and report our findings.  We will correlate our findings for significance. 
 
Power Analysis: 
Specific Aim 1, Hypotheses 1.1-1.4: To evaluate if physical therapy alone or arthroscopic labral 
repair and physical therapy is of greater benefit to patients presenting at age 40 with tears of the 
acetabular labrum. 
 Using the data from our retrospective review of outcomes following labral repair, a 10 point or 
greater difference on the mHHS as significant, and a single-tail independent t-test to evaluate the 
difference between means with 80% power and a 5% significance level, 35 subjects are needed to 
demonstrate a statistically significant difference between the average mHHS of the conservative group 
and surgical group.  Testing of hypothesis 1.5 will be an intragroup analysis looking for a significant 
difference in outcome measures from the time of completion of PT (non-crossover) when compared to the 
same data to be collected at 12 months and 24 months.  The purpose is to determine the short-term 
durability of the response to PT, if one is found. 
70 study completers should provide us with the necessary data needed to substantiate or reject 
our hypothesis. There has been no prospective trial to date testing these hypotheses in the hip, but we 
expected a 7.3-10.3% dropout rate based on the results of a similar study in the knee. However, as of 
July 2018, we had 47 patients that had passed the 2-year follow-up mark, of which 5 patients were no 
longer in the study (combination of lost to follow-up and proceeding to total hip arthroplasty), and another 
11 had yet to complete their 2-year surveys even with multiple attempts to contact them and encourage 
them to do so. With a yield of 31 patients out of 47, or 65.95%, we increased our sample size to 122. 
 
Therefore, we estimate needing 122 subjects to achieve 70 study completers, in the appropriate 
proportion of 35 subjects per treatment arm.  We enroll until reaching at least 35 subjects in each group. 

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The results of the MeTeOR trial in the knee show that we can expect a higher drop-out rate in the surgical 
group. As such, this cohort may be our limiting factor.40, 43, 61,62 
 
Specific Aim 2, Hypotheses 2.1-2.3:  To evaluate the significance of arthritic burden on short term 
outcomes following arthroscopic labral repair. 
Hypothesis 2.1 was powered on the basis of our prior work where 33% of study participants had 
grade 4 Outerbridge changes the time of arthroscopy.  Dividing our cohort into two subgroups: 1) Those 
with grade 4 changes and 2) Those without. We will need 12 subjects with grade 4 changes in order to 
perform adequate sub-group analysis.63 Powered to 80% and 5% significance level. Hypothesis 2.2 is 
another sub-group analysis that will be conducted in a similar fashion to that of hypothesis 2.1.  However, 
the two groups will be categorized into: 1) cartilage defects at or near the chondro-labral junction and 2) 
cartilage defects not at or near the chondro-labral junction.  We cannot control the heterogeneity of the 
subjects enrolled, but based on this analysis we expect to meet our target enrollment. Hypothesis 2.3 will 
be analyzed via linear regression and is appropriately powered. 
 
 
Specific Aim 3 is exploratory.  Since we are recruiting subjects for the main purposes of 
determining outcomes, we recognize that we may be underpowered for the definitive analyses of our 
radiographic correlation hypotheses.  Nevertheless, we anticipate that we will enroll sufficient numbers of 
subjects to draw an association or at the very least, trend patient outcomes with degree of joint space 
narrowing, Kellgren-Lawrence grading, and Tonnis grading.  There should also be sufficient numbers to 
preliminarily assess any correlations between pre-operative Kellgren-Lawrence and Tonnis grades with 
the Outerbridge classification at the time of arthroscopy. 
 
 
 
 
VI. RISKS & DISCOMFORTS 
Conservative Treatment:  Subjects can expect the routine discomfort associated with any therapeutic 
procedure.  Complications may include muscle soreness, pain, and increased edema or muscle fatigue. 
Operative treatment: Since surgery is not considered a research procedure (only the randomization into 
the surgery group is considered a research procedure, as explained above) surgical risks are explained in 
the surgical consent process. 
In the rehabilitation period, patients will be subject to the same potentials discomforts as those subjects in 
the conservative treatment group as the physical therapy protocols for both groups are identical. In both 
treatment groups every effort will be made to minimize the risk of adverse events and patient discomfort. 
 
 
 
VII. POTENTIAL BENEFITS: 
It is very likely that some of the subjects will derive direct benefit from participation in the study, such as 
improvements in pain and physical function. Outside of the estimated physical benefits from a surgical 
treatment or rehabilitation program, subjects may experience the monetary benefits in the forms of less 
missed work and increased productivity. There may also be the emotional benefit of being able to return 
to the normal activities of daily with a reduction in pain or no pain at all. Subjects who wish to continue 
their treatments at the conclusion of the study will be given the opportunity to do so through the Brigham 
Orthopedic Associates.  It is anticipated that findings from these studies will help advance research in 
labral repair and patient outcomes in general.  We also hope to derive a strong sense for the type of 

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patient age 40 and older who will benefit the most from either arthroscopic labral repair or physical 
therapy. 
 
VIII. MONITORING AND QUALITY ASSURANCE: 
The P.I., Dr. Martin, will oversee all data collection and ensure that data are collected and stored 
in a confidential manner consistent with all regulatory requirements.. This study will be approved by the 
Partners IRB, and any protocol deviations and/or adverse events will be reported in accordance with the 
Partners Human Research Policy. Research assistants will be trained to identify and to bring to the 
research team any complaints or adverse reactions among participants. Training will include appropriate 
steps to alleviate or remedy common problems. Dr. Martin will have contact with staff to monitor patient 
participation and any issues that emerge during the protocol, and will review and discuss human subjects’ 
protection issues with staff as unique situations emerge during the progress of the study. Dr. Martin will 
meet with the research team regularly for a formal research meeting. Subjects will be given telephone 
numbers to contact the PI and the IRB to communicate any concerns that may rise during their 
participation in the protocol. Please see below for specifics. 
1. The study staff will meet regurlarly with Dr. Martin to review study participants and the data that 
has been collected on them to date.  If a subject becomes disqualified or must leave the study for 
safety concerns, Dr. Martin will personally inform them of the situation through the subjects 
preferred method of contact. Dr. Safran-Norton will be leading and administering the 
conservative arm of the study (subjects being treated non-surgically with physical therapy and 
subjects in the post-operative period receiving rehabilitative physical therapy).  She will inform 
Dr. Martin of patient progress and any potential clinically significant events that may warrant 
further discussion and could ultimately result in the dismissal of a patient from the study. 
a. As this is a prospective study comparing the gold standard of treatment (labral repair) to 
a potentially equivalent therapeutic modality, qualifying subjects will never be denied the 
option to undergo labral repair via hip arthroscopy.  The treatment schema allows for 
subjects in the non-surgical arm (physical therapy alone) to cross over to the surgical 
treatment group at any time (following physical therapy) from initial enrollment if they wish 
to do so.  Subjects who decide to crossover or are indicated to crossover through the non 
achievement of advancement criteria will have the PT discontinued at that time point but 
must wait for official crossover at 6 weeks after initial enrollment.  Participants can always 
decide to leave the study if this is not what they want. The decision to cross over will in 
no way affect the quality of healthcare current or prior study participants receive.  All of 
this will also be explained to them during the consent. 
b. We will review all data continuously and should there be a obvious clinical detriment to 
specific treatment arm such as repeated poor outcomes or worsening function, further 
investigation will be initiated to determine if this is an isolated occurrence or if there is a 
significant trend which warrants cessation of study protocol and disenrollment of subjects. 
i. Stopping rules include a clear difference in morbidity, as measured by interval 
physical exams and outcomes questionnaires, between treatment groups 
ii. Any significant mortality possibly linked to study procedures will result in 
immediate suspension of the study protocol. 
2. A data safety monitoring board (DSMB) or data monitoring committee (DMC) is not required for 
the purposes of this study because large numbers of subjects will not be used in this 
investigation, there are no blinded treatment study groups, we are not using multiple clinical sites 
(all are within Partners network), we are not using high risk interventions (hip arthroscopy has 
been shown to be a safe option for managing intra-articular and periarticular pathology of the hip; 

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physical therapy is low risk), we are not performing a controlled trial in which major morbidity or 
mortality are considered primary or secondary endpoints. 
 
 
Adverse Events Reporting and Assessment: 
Any protocol deviations and/or adverse events will be systematically documented and reported to 
the IRB. Adverse Event Reports and/or Case Report Forms will identify study participants by their initials 
and a unique study participant identifier.: 
 
Severity grading scale: 
Mild: adverse event of little clinical significance  
Moderate: adverse event between mild and severe - causing some limitation of usual activities 
Severe: adverse event that results in death, is life-threatening, requires or prolongs hospitalization, 
causes persistent or significant disability/incapacity, represents a significant overdose or breach of 
protocol, results in congenital anomalies/birth defects or produces cancer, or in the opinion of the 
investigator, represents other significant hazards or potentially serious harm to the research subject or 
others. 
 
Attribution scale: 
Not related: clearly NOT related to the study 
Possible: may be related to the study 
Probable: likely related to the study 
Definite: clearly related to the study 
Unable to assess 
 
Any serious or unexpected adverse events will be reported to the IRB within the required 
timeframe, using the appropriate forms. The principal investigator will provide an interim report of all 
adverse events to the IRB at the time of continuing review. Although this proposed project is perceived to 
be relatively low-risk, the study may be terminated if the frequency of serious or unexpected adverse 
events is higher than that anticipated. Once this determination is made, a memo will be sent to the IRB 
explaining the reasons for the determination. For suspended studies, an action plan will be devised which 
will outline what evidence and/or conditions will be required to terminate or re-initiate the study. 
 
Reporting Unanticipated Problems including Adverse Events 
 
The principal investigator will report to the PHRC any unanticipated problems and adverse events that 
occur: 1) during the conduct of the study, 2) after study completion, 3) after subject withdrawal or 
completion.  The reports will be submitted according to PHRC policy within 5 working days or 7 calendar 
days of the date the investigator first becomes aware of the problem. 
 
Subject Confidentiality: 
Precautions will be taken when contacting and communicating with subjects to ensure that their 
participation is kept confidential. Subjects will be assured that their decision to participate will not affect 
their medical treatment. Throughout the study, investigators will be alert to any complaints or adverse 
reactions and will take appropriate steps to alleviate the difficulties as soon as possible. Subjects will be 
given the names and phone numbers of individuals to contact in the event of an emergency or a 
complaint or question regarding the conduct of the study. 

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All data for presentation will be identified by a code number only. Prior to releasing data to the 
scientific community, all data will be de-identified. Explicit permission to share the de-identified data with 
the scientific community will be obtained as part of the Informed Consent procedures. 
 
Safeguarding Specimens, Records, and Data: 
All research materials are obtained directly from the participants by trained and supervised study 
staff. All study staff who interact with human subjects have completed the requisite training in research 
ethics and procedures, and are approved by the institution’s IRB. Each participant in the study will be 
assigned a study ID number as a unique identifier. All records and research data will be kept in locked 
filing cabinets and on password-protected, secure computer systems. Databases that link Personal 
Health Information with research data will be kept on secure, Partners computer systems.  Only 
summaries of group data will be reported in any publications or presentations, with no identification of 
individual.

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62. Wilson, S.R. and I. Gordon, Calculating Sample Sizes in the Presence of Confounding Variables. 
J Royal Statisitical Soc, 1986. 35(2): p. 207-13. 
63. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in Medicine — Reporting of 
Subgroup Analyses in Clinical Trials. N Engl J Med (2007); 357(21): 2189-94.  
 

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 1 of 10
Subject Identification
Protocol Title: Arthroscopic Labral Repair versus Physical Therapy for Tears 
of the Acetabular Labrum in Patients Age 40 and Older
Principal Investigator: Dr. Scott D. Martin
Site Principal Investigator: MGH and BWH
Description of Subject Population: Adults age 40 or greater with a tear of the 
acetabular labrum
About this consent form
Please read this form carefully.  It tells you important information about a research study.  A 
member of our research team will also talk to you about taking part in this research study.  
People who agree to take part in research studies are called “subjects.”  This term will be used 
throughout this consent form.
Partners HealthCare System is made up of Partners hospitals, health care providers, and 
researchers.  In the rest of this consent form, we refer to the Partners system simply as 
“Partners.”
If you have any questions about the research or about this form, please ask us.  Taking part in 
this research study is up to you.  If you decide to take part in this research study, you must sign 
this form to show that you want to take part.  We will give you a signed copy of this form to 
keep.
Why is this research study being done?
We are doing this study to learn whether physical therapy (PT) alone or surgery and PT is more 
effective at treating the symptoms of a torn acetabular labrum (torn fibrocartilage in the hip 
joint). PT and surgery are both considered standard medical care for your kind of hip injury.
We are asking you to take part in this study because you have a tear of the acetabular labrum.
 
This is a pilot study. Pilot studies are done on a small group of people to learn whether a larger 
study would be useful. 
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 2 of 10
Subject Identification
About 122 people will take part in this study. This study is being done at Massachusetts General 
Hospital, MGH West, Brigham and Women’s Faulkner Hospital, and the Patriot Place Health 
Care Center at Foxborough. 
Smith & Nephew is helping to pay for this study to be done.
How long will I take part in this research study?
Depending on what treatment you are assigned, the length of certain study procedures will differ. 
If you are assigned to physical therapy, you will have 3-4 months of physical therapy sessions 1-
2 times a week followed by 3-4  months of self-directed home physical therapy. If you are in the 
surgery group, you will also undergo 3-4 months of physical therapy, which will start within two 
weeks of your surgery followed by 3-4  months of self-directed home physical therapy. If you 
switch from physical therapy to surgery, you will undergo 3-4 months of physical therapy after 
your surgery, meaning that you may undergo more than 3-4 months of physical therapy in total. 
After this, you will also undergo 3-4  months of self-directed home physical therapy. 
Participation in this study entails taking surveys at time points closely mirroring your 
postoperative follow-up schedule with Dr. Martin. These surveys will be sent to you for as long 
as you are a patient of Dr. Martin’s or until you tell us that you do not want to receive any more 
surveys. Follow-up with Dr. Martin after your surgery will start out being a few times a year for 
the first year and will progress to once yearly or once every few years thereafter. Therefore, you 
will receive, at most, one survey a year after your first year of follow-up. Surveys take 
approximately 15-20 minutes to complete.  
What will happen in this research study?
If you choose to take part in this study, we will ask you to sign this consent form before we do 
any study procedures. 
After your normal clinical visit with Dr. Martin, he will let you know if you qualify for this 
research study. If you choose to participate, we will assign you to a study group. We will assign 
you by chance (like a coin toss) to the PT alone group or the surgery with PT group. You and the 
study doctor cannot choose your study group.  You will have a 1 in 2 chance of being assigned to 
the PT alone group and a 1 in 2 chance of being assigned to the surgery with PT group. While 
you will have some PT no matter which group you are in, the exercises you will do at PT are 
different depending on whether you are having surgery or not. 
 
We will have you complete a set of baseline surveys about your hip problem and your general 
health. We can email you these surveys so you can complete them at home. 
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 3 of 10
Subject Identification
The Partners standard is to send email securely. This requires you to initially set up and activate 
an account with a password. You can then use the password to access secure emails sent to you 
from Partners HealthCare. If you prefer, we can send you “unencrypted” email that is not secure 
and could result in the unauthorized use or disclosure of your information. If you want to receive 
communications by unencrypted email despite these risks, Partners HealthCare will not be held 
responsible. Your preference to receive unencrypted email will apply to emails sent from this 
research group/study only.
Hip Surgery (Surgery group only)
If you are assigned to the hip surgery with PT group, you will come in for surgery on your hip. 
This visit will take about 4-6 hours.  After surgery, you will be monitored for 2-3 additional 
hours.  The surgery will be performed as usual. We may videotape parts of your surgery. 
Physical Therapy Visits
All participants, regardless of the treatment group you are in, will make up to 24 visits for PT 
during the study. These visits will take place once or twice a week for about 4 months and will 
take about one hour each. The physical therapist will meet with you at these visits and have you 
do exercises to increase the strength and flexibility of your hip. There are several differences in 
the type of PT each group receives:

If you receive only PT: The PT will be immediately directed to improve strength, 
increase the range of motion at your hip, and reduce pain associated with your hip.

If you receive surgery and then PT: The PT will be directed to improve strength, 
increase range of motion at your hip, and reduce pain associated with your hip.  
However, in the first four weeks after your surgery, we are careful to not reinjure 
your hip.  For this reason, you will have restrictions on physical activity.  After the 4 
weeks, we will increase your activity 
Crossover
If you are in the PT only group, you will be evaluated at every PT session to see how effective 
the PT is. If you, the physical therapist, or your doctors find the treatment to be ineffective the 
physical therapy will be stopped. We hope most people will try PT for 6 weeks before deciding 
to switch but you will be allowed to crossover to surgical treatment at any time point and remain 
in the study. However, surgery may be scheduled for a date that is at least 6 weeks after your PT 
start date. As part of the process to switch from PT to surgery, you will be scheduled for re-
evaluation by the surgeon within two weeks of the last PT visit you went to.
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 4 of 10
Subject Identification
Regardless of which treatment you are receiving, we will continue to send you surveys around 
your regular clinical follow up visits with Dr. Martin. We estimate these surveys will take about 
20 minutes to complete. 
Study Phone Calls
During this study, we may call you to follow up with questions about survey responses and to 
give you friendly reminders to complete the surveys. 
Storage and Use of your Study Information 
During this study, we will store your study information in a secure electronic database used for 
research. 
We will label your study information with a code instead of your name. The key to the code 
connects your name to your health information. We will keep the key to the code on a password-
protected computer. We will also collect your personal contact information which includes your 
name, address, telephone numbers, and email address.  This information will be shared with staff 
participating in the study if you need to be contacted.  This information will also be stored 
securely in REDcap.  All paper study information forms will be kept in a locked file cabinet.
Future Studies
We would like to contact you 4 years after you finish your study treatment year, so that we can 
evaluate the long-term outcome of hip problems like yours. We will ask you to come to the clinic 
for a brief physical exam and to complete questionnaires. The questionnaires can be emailed to 
you one week before your clinic visit. The visit will take about 15-45 minutes depending on if 
the questionnaires were completed before coming to your visit.
Do you agree to be contacted and to complete an extra study visit one time, at 5 years after you 
start this study?  
    
YES______(Subject’s Initials)
NO______(Subject’s Initials)
What are the risks and possible discomforts from being in this research 
study?
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 5 of 10
Subject Identification
Risks of Hip Surgery
If you are assigned to the surgery group, you will be exposed to all of the clinical risks associated 
with your hip surgery. These risks include: 

Nausea

Pneumonia (lung infection)

Infection in the hip

Blood clots in the lungs or legs

Heart attack 

Injury to nerves 

Death 
There is also a small possibility that you might have an allergic reaction to the bandage used 
after surgery.  Signs of an allergic reaction include rash, itching, skin problems, swelling of the 
face and throat, or trouble breathing. If you think you are having an allergic reaction, call the 
study doctor right away. If you are having trouble breathing, call 911 immediately. 
Risks of Physical Therapy
Risks of PT include: 

Locking in your hip

Muscle pain in the knee, hip, back, or neck 

Injury to tendons or ligaments 
Unknown Risks 
There may be other risks of this study that are currently unknown. We will tell you if we learn 
any significant new information about risks that may affect your willingness to stay in this study.
What are the possible benefits from being in this research study?
You may or may not benefit from taking part in this study. Whether you are assigned to PT alone 
or surgery and PT, it is possible that the pain in your hip might improve.  The information from 
this study may help us to give the best treatment to future patients with tears of the acetabular 
labrum.
What other treatments or procedures are available for my condition?
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 6 of 10
Subject Identification
You do not have to take part in this study to receive treatment for your acetabular labral tear. 
You can receive PT and surgery outside of the study.
Will I be paid to take part in this research study?
You will not be paid to take part in this study.
 What will I have to pay for if I take part in this research study?
You and your insurance company will be responsible for the cost of the surgery and/or physical 
therapy you receive in this study because this would be needed for your care even if you are not 
in the study.
Can I still get medical care within Partners if I don’t take part in this 
research study, or if I stop taking part? 
Yes.  Your decision won’t change the medical care you get within Partners now or in the future.  
There will be no penalty, and you won’t lose any benefits you receive now or have a right to 
receive.
Taking part in this research study is up to you.  You can decide not to take part.  If you decide to 
take part now, you can change your mind and drop out later.  We will tell you if we learn new 
information that could make you change your mind about taking part in this research study.
What should I do if I want to stop taking part in the study?
If you take part in this research study, and want to drop out, you should tell us.  We will make 
sure that you stop the study safely.  We will also talk to you about follow-up care, if needed.
It is possible that we will have to ask you to drop out before you finish the study.  If this 
happens, we will tell you why.  We will also help arrange other care for you, if needed.
What happens if I am injured as a result of taking part in this research 
study?
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 7 of 10
Subject Identification
We will offer you the care needed to treat any injury that directly results from taking part in this 
research study.  We reserve the right to bill your insurance company or other third parties, if 
appropriate, for the care you get for the injury.  We will try to have these costs paid for, but you 
may be responsible for some of them.  For example, if the care is billed to your insurer, you will 
be responsible for payment of any deductibles and co-payments required by your insurer.
Giving you care does not mean that Partner’s Hospitals or researchers are at fault, or that there 
was any wrongdoing
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay 
you or give you other compensation for an injury, should one occur.  However, you are not 
giving up any of your legal rights by signing this form.
If you think you have been injured or have experienced a medical problem as a result of taking 
part in this research study, tell the person in charge of this study as soon as possible.  The 
researcher's name and phone number are listed in the next section of this consent form.
If I have questions or concerns about this research study, whom can I 
call?
You can call us with your questions or concerns.  Our telephone numbers are listed below.  Ask 
questions as often as you want.  
Dr. Scott D. Martin, M.D., Associate Professor of Orthopedic Surgery at Harvard Medical 
School is the person in charge of this research study.  You can call him at (617)-732-5329, 
Monday through Friday from 9 a.m. to 5 p.m. He can be reached during evenings and on 
weekends by calling (617)-732-6660 at pager number 16414.  You can also call Dr. Clare 
Safran-Norton, PT, PhD, OCS at 617-732-5304, Monday through Friday from 9 a.m. to 5 p.m. 
with questions about this research study.
If you have questions about the study, you can call the research coordinator at 617-643-0886, 
Monday through Friday from 8:30 a.m. to 5:00 p.m.  
If you want to speak with someone not directly involved in this research study, please contact 
the Partners Human Research Committee office.  You can call them at 857-282-1900.
You can talk to them about:

Your rights as a research subject

Your concerns about the research
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 8 of 10
Subject Identification

A complaint about the research
Also, if you feel pressured to take part in this research study, or to continue with it, they want to 
know and can help.
If I take part in this research study, how will you protect my privacy?
During this research, identifiable information about your health will be collected.  In the rest of 
this section, we refer to this information simply as “health information.”  In general, under 
federal law, health information is private.  However, there are exceptions to this rule, and you 
should know who may be able to see, use, and share your health information for research and 
why they may need to do so.   
In this study, we may collect health information about you from:

Past, present, and future medical records

Research procedures, including research office visits, tests, interviews, and 
questionnaires
Who may see, use, and share your identifiable health information and why they may 
need to do so:

Partners research staff involved in this study

The sponsor(s) of this study, and the people or groups it hires to help perform this 
research

Other researchers and medical centers that are part of this study and their ethics boards

A group that oversees the data (study information) and safety of this research

Non-research staff within Partners who need this information to do their jobs (such as for 
treatment, payment (billing), or health care operations)

The Partners ethics board that oversees the research and the Partners research quality 
improvement programs.

People from organizations that provide independent accreditation and oversight of 
hospitals and research

People or groups that we hire to do work for us, such as data storage companies, insurers, 
and lawyers

Federal and state agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health, and other US or foreign 
government bodies that oversee or review research) 
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 9 of 10
Subject Identification

Public health and safety authorities (for example, if we learn information that could mean 
harm to you or others, we may need to report this, as required by law)

Other:       
Some people or groups who get your health information might not have to follow the same 
privacy rules that we follow.  We share your health information only when we must, and we ask 
anyone who receives it from us to protect your privacy.  However, once your information is 
shared outside Partners, we cannot promise that it will remain private.
Because research is an ongoing process, we cannot give you an exact date when we will either 
destroy or stop using or sharing your health information.
The results of this research study may be published in a medical book or journal, or used to teach 
others.  However, your name or other identifying information will not be used for these purposes 
without your specific permission.
Your Privacy Rights
You have the right not to sign this form that allows us to use and share your health information 
for research; however, if you don’t sign it, you can’t take part in this research study.   
You have the right to withdraw your permission for us to use or share your health information 
for this research study.  If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing.  Once permission is withdrawn, you cannot continue to 
take part in the study.
If you withdraw your permission, we will not be able to take back information that has already 
been used or shared with others.
You have the right to see and get a copy of your health information that is used or shared for 
treatment or for payment.  To ask for this information, please contact the person in charge of this 
research study.  You may only get such information after the research is finished. 
Informed Consent and Authorization
Statement of Study Doctor or Person Obtaining Consent

I have explained the research to the study subject.
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A

Partners HealthCare System
Research Consent Form
General Template
Version Date:  February 2010
Page 10 of 10
Subject Identification

I have answered all questions about this research study to the best of my ability.
Study Doctor or Person Obtaining Consent
Date/Time
Statement of Person Giving Informed Consent and Authorization

I have read this consent form.

This research study has been explained to me, including risks and possible benefits (if 
any), other possible treatments or procedures, and other important things about the study.

I have had the opportunity to ask questions.

I understand the information given to me.
Signature of Subject:
I give my consent to take part in this research study and agree to allow my health information to 
be used and shared as described above.
Subject
Date/Time
Consent Form Version:  7.7.19 PA 
Consent Form Title: RCT_Consent Form_7.7.19--Clean
IRB Protocol No: 2013P001442
Sponsor Protocol No: Clean Detailed Protocol-v4.0
Consent Form Valid Date: 2/5/2021
IRB Amendment No: N/A
Sponsor Amendment No: N/A
Consent Form Expiration Date: 2/3/2022
IRB Amendment Approval Date: N/A