A Randomized Controlled Trial to Compare Single Portal Versus Two Portal Knee Arthroscopy Techniques in Patients With Meniscal Injuries and Articular Cartilage Pathology
Phase: NA
Conditions: Injuries, Knee
Sponsor: Wake Forest University Health Sciences

Version Date:  05.03.2018  
 
Study Title: A randomized controlled trial to compare single portal versus two portal knee 
arthroscopy techniques in patients with meniscal injuries and articular cartilage pathology 
 
NCT02648971 
 
IRB Approval Date:  5/8/18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
Version date: 05.03.2018 
 
 
Study Title: A randomized controlled trial to compare single portal versus two portal knee 
arthroscopy techniques in patients with meniscal injuries and articular cartilage pathology 
 
Principal Investigator: John B. Hubbard, MD 
Sub-Investigator: David F. Martin, MD 
 
Sponsor or funding source: Stryker Endoscopy, San Jose, CA 
 
Background, Rationale and Context 
 
 
Knee arthroscopy procedures provide a minimally invasive method to assess the status of 
the knee joint in order to repair injuries of the meniscus and articular cartilage. In the past, two or 
more small openings in the skin (portals) were required in order to allow the passage of both an 
arthroscope to provide visualization of the knee joint and the instrument used to complete the 
surgical repair process. However, recent innovations in arthroscopy instrumentation have 
resulted in the ability to use one portal for knee arthroscopy procedures with both the arthroscope 
and the instruments passed into the knee joint through the same portal. Both uniportal and two 
portal arthroscopic techniques are used currently for knee arthroscopy procedures in the 
Department of Orthopaedic Surgery at Wake Forest Baptist Health. 
 
Objectives 
 
This randomized, controlled clinical trial will compare the outcomes of single portal 
versus two portal techniques in patients who have meniscus or articular cartilage pathology. The 
study hypothesis is that patients who undergo single portal arthroscopy will have less pain post-
operatively, use less pain medication, and have a higher International Knee Documentation 
Committee (IKDC) score at six months and one year compared to patients who undergo 
traditional two portal knee arthroscopy.  
 
Methods and Measures 
 
Design:  A randomized, controlled trial 
 
Setting: Academic Medical Center: single study site at Wake Forest Baptist Health 
 
Subjects selection criteria 
 
Inclusion Criteria 
• Men and women between 21 and 65 years of age, who agree to comply with the 
protocol 
• Patients undergoing a primary knee arthroscopy procedure for meniscus or articular  
   cartilage pathology 
 
Exclusion Criteria 

3 
Version date: 05.03.2018 
• Patients with a history of long term pain medication use and/or chronic pain conditions 
unrelated to the surgery. 
 Subjects with severe renal disease, allergies to pain medication, and subjects that will 
have adverse drug-drug reactions from prescribed pain medication.  
• Patients with previous reconstructive procedures, lateral retinacular release, or  
   microfracture 
• Active knee infection or sepsis at the time of surgery 
• Meniscal injuries requiring repair 
• Ligamentous instability 
• Advanced degenerative or inflammatory arthritis 
• Known cancer at the time of surgery 
• Conditions that might interfere with recovery from knee arthroscopy (i.e. conditions or  
   diseases of the nervous and/or muscular system, vascular disease, uncontrolled  
   diabetes) 
• Malignant tumor history or treatment of malignant tumor of the knee 
• Lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle  
   arthroplasty, previous hip fracture, knee arthrofibrosis) 
• Pregnant, breast feeding, or planning on becoming pregnant during the time frame of 
the study, (if a woman of child-bearing age) 
• Emotional or neurological conditions that affect the subject’s ability or willingness to  
   participate in the study including mental illness or drug and/or alcohol abuse 
• Severely overweight (BMI >40) at study enrollment or surgery  
• Currently participating in another research study 
• Prisoner or impending imprisonment 
• Workers’ Compensation claims 
 
Sample Size: 
 
Power calculations were performed based on data from previous studies. Van de Graaf 
found a standard error of the mean (SEM) of 5.3 and a smallest detectable difference (SDD) of 
14.6 for the Subjective Knee Evaluation Form part of the International Knee Documentation 
Committee (IKDC).(2) These measures were slightly larger than the SEM of 4.6 and the SDD of 
9.0 reported by Irrgang.(1) Based on these values, power calculations identified the desired 
sample size as 50 patients in each surgical group to yield 84.7% power to detect a difference with 
an alpha = 0.05. In order to account for 10% missing data due to patient drop-outs and/or loss to 
follow-up, a total of 110 patients will be randomized and enrolled with 55 patients in each of the 
two surgical groups. The blocked randomization scheme will be designed for the potential 
enrollment of 60 patients in each of the two study groups. 
 

4 
Version date: 05.03.2018 
Interventions and Interactions 
 
 
Evaluation Schedule Summary: 
Evaluation 
History 
/ Pre-
Op 
Intra-
Op 
 
1 
day 
 
4 
days 
 
1 
week 
 
30 
days 
± 7 
days 
 
3 
months 
± 2 
weeks 
6 
months 
± 2 
weeks 
 
1 year 
± 1 
month 
Patient  
     ●  IKDC 
demographics 
X 
 
 
 
 
 
 
 
 
     ●  IKDC current 
health 
X 
 
 
 
 
 
 
X 
X 
     ●  IKDC 
subjective knee 
evaluation 
X 
 
 
 
 
X 
X 
X 
X 
Patient phone 
calls  
    •   Pain 
scores/pain 
medication log 
 
 
 
X 
 
X 
 
 
 
 
 
 
 
Physician 
     ●  IKDC knee 
history 
X 
 
 
 
 
 
 
 
 
  ● IKDC 
surgical 
documentation 
form 
 
X 
 
 
 
 
 
 
 
     ● IKDC knee 
examination form 
X 
 
 
 
 
X 
X 
X 
X 
 
Document 
rehab 
duration  
 
 
 
 
 
X 
X 
 
 
Stitch Removal/ 
Postop Follow-up 
for Pain/Meds 
 
 
 
 
 
X 
 
 
 
 
 
 
 
      
The study will include six visits: one pre-surgery visit and five post-surgery visits at one 
week, 30 days, three months, six months, and one year. The one week, 30 day, and three month 
follow-up visits coincide with the standard of care follow-up visits for patients who undergo 
knee arthroscopy. The six month and one year visits will be for research purposes and will not be 
billed to insurance providers.   

5 
Version date: 05.03.2018 
Additionally, the patients will be contacted by phone at 1and 4 days after surgery to 
determine their visual analog pain scores and their use of pain medications. Patients will also 
keep a daily log of their pain level and use of pain medications. These calls will also be used to 
remind patients to complete their pain diaries. 
Randomization: A blocked randomization scheme (block size of 10) will be used to 
assign study participants to either single portal (Group 1) or two portals (Group 2) knee 
arthroscopy. Prior to surgery, the surgeon will log on to the randomization website to determine 
each participant’s surgical group assignment. After randomization for each patient is complete, 
the website will document the name of the person who logged on to perform the randomization, 
the date and time of the log in, and the surgical group assignment for each patient. In addition, 
the website will document the patient’s name, medical record number, and study treatment 
allocation. This randomization information will be forwarded to the operating room staff so that 
they can prepare for each study participant’s surgical procedure. 
If during the surgical procedure, a patient who was randomized to the single portal 
technique is found to require a two portal technique, this patient will be recorded as a treatment 
cross-over as long as the patient continues to meet inclusion criteria. This will also be true for 
patients randomized to the two portal technique who undergo the single portal technique.  Cross-
over patients will not be excluded from the study. We are anticipating that only a small number 
of patients will be cross-over patients. 
Surgery: Patients in Group 1 will undergo knee arthroscopy using a single portal. Patients 
in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical 
procedure for each study participant will be documented on the IKDC Surgical Documentation 
Form. 
Post-surgical follow-up: Study participants in each group will return for standard post-
operative follow-up visits at one week, 30 days, and three months. They will return to the clinic 
at six months and one year for study visits. These two visits will not be billed to insurance 
providers.  
 
Outcome Measures 
Patient assessments:  
Patients will complete the patient-related IKDC questionnaires at each study visit except 
the one week visit. The IKDC is used to monitor knee symptoms, function, and activity level (1) 
The IKDC was developed and revised by knee experts as a knee-specific rather than a disease-
specific evaluation. (1) A recent study by Van de Graff, et al demonstrated that the IKDC was 
better in all its measurement properties than the KOOS or the WOMAC for evaluating patients 
with meniscal injuries. (2)  
 

6 
Version date: 05.03.2018 
At the pre-surgery visit, study participants will complete several components of the 
IKDC questionnaires including the demographic form, current health assessment form, and the 
subjective knee evaluation form. Patients will maintain a daily log to document their use of pain 
medications for the first two weeks after surgery. In addition, study participants will complete 
the subjective knee evaluation form at one month, three months, six months, and one year.  
Patients will be contacted by phone on post-surgical days 1 and 4 to remind them to 
complete their daily log and to report their pain level and medication use. At each phone call and 
clinic visit, patients will be asked two questions: 1. What day did you feel that you had completed 
recovering from the surgery? and 2. What day did you stop taking pain medicine? Patients also 
will be asked these questions at the 30 day clinic visit. 
If patients are unable or decline to return to clinic for follow-up, we will try to collect the 
patient-completed questionnaires either by telephone, by mail, or by a web-based link sent to 
them via a REDCap database survey at any study time point. 
 
Physician assessments: 
The principal investigator will complete the IKDC knee history form, surgical 
documentation form and knee examination form at baseline. At 30 days, three months, six 
months, and one year the physician assistant or other designee will complete the knee 
examination form. Additionally, the rehabilitation duration will be noted at the 30 days and three 
month visit per patient report.  
 
Patient Retention 
Every effort will be made to retain patients in the study to ensure complete data 
collection. During the study consent process, potential study participants will be educated 
regarding the importance of full participation in all visits. Study participants will be called at 1 
day and 4 days after surgery. At these calls, patients also will be reminded of their upcoming 
appointments. Patients will also be reminded about their follow-up visits at all clinic visits. 
Patients will also be given an information packet about the study. This packet will include a list 
of the dates for the phone calls and the dates of their follow-up clinic visits.  
If patients are unable or decline to return to clinic for follow-up, we will try to collect the 
patient-completed questionnaires either by telephone, by mail, or a web-based link sent to them 
via a REDCap database survey at any study time point. 
 
Analytical Plan 
 
Primary outcome: The IKDC Subjective Knee Evaluation Form score will be the 
primary outcome measure. The IKDC subjective knee form contains 19 questions and requires 
approximately five minutes to complete.(2) All except one of the items is converted to a score; a 

7 
Version date: 05.03.2018 
maximum score of 100 indicates that the patient has no restrictions in their daily activities or 
sports and does not have any knee symptoms.(2) 
 
Secondary outcome: Pain levels and the use of pain medication will be monitored by 
study participants using a daily pain diary. The pain diary will be used for the first two weeks 
after surgery. Pain levels will also be collected at the 1 and 4 day telephone calls. A pain rating 
will also be collected at the one week, 30 day, three months, six months, and one year visit. 
Data management: All study data will be entered into a REDCap database. The database 
will be HIPAA compliant and will meet all the requirements of the NIH and FDA. The REDCap 
server is behind a firewall and is backed up every 24 hours. The data will be sent as an Excel 
spreadsheet for analysis to biostatisticians in the Section on Biostatistics of the Department of 
Public Health Sciences at Wake Forest School of Medicine. 
 
Human Subjects Protection 
 
All patients with a diagnosis of meniscal or appropriate articular cartilage injury will be 
screened for inclusion into the study. 
This study will be conducted in accordance with the current IRB-approved clinical 
protocol; ICH GCP Guidelines adopted by the FDA; relevant policies, requirements, and 
regulations of the clinical test site IRB; and applicable federal agencies. 
Subjects may withdraw from the study at any time for any reason at their request.  
Otherwise, participants will be followed as per the protocol.  Attempts will be made to collect 
clinical data from withdrawn subjects.  There will be no replacement of subjects who withdraw 
from the study.    
 
Subject Recruitment Methods 
 
The study will recruit patients who present to the Orthopaedic Sports Medicine Clinic at 
Wake Forest Baptist Health with symptoms requiring arthroscopic knee surgery for meniscal or 
articular cartilage pathology.  
 
Study screening and enrollment: Potential study participants will be screened in the 
Orthopaedic Sports Medicine Clinic. Patients with meniscus injuries who meet the study 
inclusion criteria will be told about the study and will be asked if they would like to participate. 
The study will be described, and the requirements for study participation will be explained. 
Potential study participants will be encouraged to ask questions about the study and to find out 
what is involved in study participation. A patient information sheet will be provided to the 
potential subject to explain the study and used as a recruitment tool. Patients who agree to 

8 
Version date: 05.03.2018 
participate will be asked to provide informed consent. No study related procedures will occur 
until after the informed consent is obtained. Following completion of informed consent, the 
study participants will be asked to complete three of the six IKDC forms including 
questionnaires to document demographics, current health, and subjective knee evaluations. 
 
Informed Consent 
 
 
Signed informed consent will be obtained from each subject in the privacy of a clinical 
examination room. The study coordinator will discuss the study with patients who meet study 
entry criteria and will obtain consent while the patients are in the clinic following their visit with 
the surgeon. 
 
Confidentiality and Privacy 
 
 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner.  To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection form.  Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, stored separately from the data.  The linkage file 
will be kept secure, with access limited to designated study personnel.  Following data 
collection, subject identifying information will be destroyed six years after closure of the study 
by shredding the paper documents and deleting the information from the computer files, 
consistent with data validation and study design, producing an anonymous analytical data set.  
Data access will be limited to study staff.  Data and records will be kept locked and secured, with 
any computer data password protected.  No reference to any individual participant will appear in 
reports, presentations, or publications that may arise from the study. 
 
 
Data and Safety Monitoring 
 
 
The principal investigator will be responsible for the overall monitoring of the data and 
safety of study participants.  The principal investigator will be assisted by other members of the 
study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
 
 
Any unanticipated problems, serious and unexpected adverse events, deviations or 
protocol changes will be promptly reported by the principal investigator or designated member 
of the research team to the IRB and Stryker Endoscopy, or appropriate government agency if 
appropriate. 
 
 
Update to the study protocol: 
 
The study sponsor, Stryker, Inc. has made a business decision to no longer fund or 
support the continuation of the study. The study team is unaware of any serious adverse events or 

9 
Version date: 05.03.2018 
unanticipated risks to patients during the course of the study. Study participants will be offered a 
final close-out clinical examination visit of their study knee if they have not completed the study 
visits. This final research visit will be at no-charge to the patient or to their insurance company.  
 
This final study visit will consist of a brief knee exam by a member of the study team and we 
will measure how well the patient can bend and straighten their knee (their range of motion). We 
would also ask the patient to answer a short survey about their knee function and pain. This 
survey is the same questionnaire the patient would have completed during the study at their 
regular study follow-up visits (the IKDC Knee Examination Form and IKDC Current Health 
Assessment Form). We anticipate this visit will take approximately 15-20 minutes.  We still offer 
patient compensation of $10 for completion of this final study visit. 
 
If the patient is having any other issues with their study knee, with their knee on the other side, 
or any other orthopaedic problems and would like to see an orthopaedic surgeon, we will offer to 
schedule an appointment for the patient as a regular clinical visit. However, the patient and/or 
their insurance provider will be charged for this appointment. 
 
If the patient chooses not to return to the clinic for the knee exam, we will ask them to complete 
the final brief survey about their knee function and pain. This survey may be completed either on 
the telephone or by email through an electronic survey. If the patient declines to participate in 
this final knee exam and/or survey, we will note their decision and not contact the patient any 
further about this study. 
 
Patients will be transferred to clinical management of their knee and they will be followed as part 
of standard clinical care by their orthopaedic surgeon in the future. 
 
References 
 
(1) Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, et al. Development 
and validation of the international knee documentation committee subjective knee form. Am J 
Sports Med 2001 Sep;29(5):600-13. 
(2) van de Graaf V, Wolterbeek N, Scholtes VA, Mutsaerts EL, Poolman RW. Reliability and 
Validity of the IKDC, KOOS, and WOMAC for Patients With Meniscal Injuries. Am J Sports 
Med 2014 Mar 11. 
(3) Cooper DE, Fouts B. Single-portal arthroscopy: report of a new technique. Arthrosc Tech 
2013;2(3):e265-e269. 
(4) Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness 
of the IKDC score for meniscus injuries of the knee. Arthroscopy 2007 Aug;23(8):839-44. 
Appendix 
 
1. International Knee Documentation Committee questionnaires 
 Patient Questionnaires 
 Physician Questionnaires 
 
2.  Pain logs