Treatment of Hallux Rigidus With Synthetic Hemiarthroplasty Versus Cheilectomy: A Randomized Controlled Trial
Phase: NA
Conditions: Hallux Rigidus
Sponsor: University of Wisconsin, Madison

 
 
Treatment of Hallux Rigidus with Synthetic Hemiarthroplasty versus Cheilectomy: A randomized 
controlled trial 
PI: Dr. Kurt Rongstad University of Wisconsin Department of Orthopedics and Rehabilitation 
Protocol Version 1 – 7/22/2019 
Co-Investigators: Dr. Andrew Brooks, Dr. Kathryn Williams (Garrels), Dr. Ronald Guiao 
 
NCT03935880 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Project Summary:  
 
Arthritis of the first metatarsophalangeal joint, otherwise known as hallux rigidus, is a 
common medical condition affecting approximately 2.5% of patients over the age of 50. 1 It is a 
progressive disorder that leads to pain, stiffness and altered gait mechanics. While non-operative 
management can be successful in some patients, many will undergo symptomatic worsening that 
can lead to the discussion of surgical intervention. While there are multiple surgical options 
available, Cheilectomy has become common practice for lower grade hallux rigidus, with 
arthrodesis (joint fusion) being common practice for higher grade hallux rigidus. There has been a 
push for additional options, however, to achieve adequate pain control, with maintenance of joint 
motion. Multiple joint replacement type procedures have been introduced with varying levels of 
success. The recent introduction of a polyvinyl alcohol implant called Cartiva, has been quite 
promising. Multiple studies have shown the safety and efficacy of this implant used in patients with 
moderate and high-grade hallux rigidus. Both 2 and 5 year follow up studies have shown continued 
improvement in pain relief and quality of life scores, with minimal negative side effects. 2,3 
However, the primary outcome measures in studies up to this point have compared results 
between patients undergoing Cartiva implant vs. those undergoing arthrodesis. At the time of this 
writing, there has yet to be any investigation into patient results following cheilectomy versus 
Cartiva implant. While both procedures are indicated for patients with grade 2 hallux rigidus, there 
has not been a randomized clinical trial performed to compare these two procedures in a cohort of 
patients with grade 2 hallux rigidus. Furthermore, there is no data at this time as to patient 
characteristics that would make them a better candidate for one procedure or the other.  
Background and Significance:  
 
Hallux Rigidus is a common disorder that affects an estimated 1 in 40 people over the age 
of 50.4 While debate remains about the primary cause of this disorder, it is likely multifactorial with 
contributing factors including previous trauma, malalignment and underlying genetic influences.5 
Regardless of the cause, the disorder can become progressive and significantly impact a patient’s 
quality of life. Common symptoms include pain, swelling and limited range of motion. Patients 
often present with pain dorsally over the first metatarsophalangeal (MTP) joint secondary to 
osteophyte formation and swelling. This can restrict range of motion at this joint, as well as make 
daily activities, such as wearing closed-toed shoes, quite difficult.6 Furthermore, continued pain can 
lead to gait abnormalities with more weight bearing through the lateral aspect of the foot and 
potential transfer metatarsalgia.7  
 
Along with physical exam to identify first MTP range of motion, joint swelling, erythema 
and palpable osteophyte formation, radiographic evaluation is part of the standard of care in hallux 
rigidus evaluation. Coughlin and Shurnas proposed a grading system that has become widely used, 
based on the radiographic findings and range of motion at the MTP joint.8 The grading system 
allowed clinicians to characterize patients from grade 0-4, helping guide treatment decisions.  
 
Initial treatment is centered on pain relief with non-operative modalities. Modified shoe 
wear, custom orthotics with a Morton extension and activity modifications have all been shown to 
improve symptoms in some patients.7 For patients that fail non-operative therapies, a wide array of 
surgical options exist. For patients with Grade 1 and 2 hallux rigidus, joint sparing procedures have 

 
 
been primarily used, with the most common procedure being Cheilectomy. The Cheilectomy 
procedure involves removal of the dorsal osteophytes and 20-30% of the dorsal metatarsal head.3 
The benefits of this procedure include the ability to improve joint mobility, while still leaving the 
potential for future fusion. Success rates have been reported between 72% and 100% in patients 
with grade 1 and 2 hallux rigidus.7  
 
Joint fusion has become common place in the treatment of advanced stage hallux rigidus, 
including grade 3 and 4. High fusion rates and patient satisfaction has been proven with fusion 
procedures in the first MTP joint.7 However, the loss of motion at the first MTP joint associated 
with the fusion procedure can interfere with activities such as running and jumping, and can make 
shoe wear choices difficult2. These limitations led to the push for development of a joint 
replacement procedure, allowing for pain control and continued motion.  
 
The use of silicone-based joint replacement has been met with mixed results, however 
concerns over the durability leading to implant fracture, osteolysis and difficulty of revision 
procedures has ultimately limited its use.9 Ceramic implants were found to have good short-term 
results, however concerns remain regarding the large amount of subsidence seen in follow up, as 
well as potential osteolysis10. Furthermore, the amount of bone stock remaining following this 
procedure could make revision procedures quite challenging. Given these mixed results, there 
remained a significant drive to identify a joint replacement-type procedure with a device that could 
maintain adequate bone stock, preserve motion and withstand the daily stresses the first MTP joint 
faces.  
 
This led to the use of the Cartiva implant, a polyvinyl alcohol hydrogel implant. Following 
extensive safety and wear testing, it was determined that this implant would be well suited for use 
in patients with hallux rigidus. Indicated for grade 2, 3 and 4 hallux rigidus, the initial study of 
Cartiva effectiveness compared outcomes of the implant versus arthrodesis. The prospective, 
randomized control trial evaluated 202 patients, with over 2/3 undergoing the Cartiva procedure.2 
Both short and midterm outcomes were very promising. 5-year revision rates were found to be 5% 
with no evidence of implant loosening or surrounding bone complication.11 Additionally, the Cartiva 
implant was found to be equivalent to the gold standard, arthrodesis, when it came to post-
operative patient outcome scores, range of motion and complications.2  
 
With promising results from initial clinical trials, further evaluation into the efficacy and 
indications for Cartiva is necessary. To date, there is no published literature comparing Cheilectomy 
to Cartiva. Both procedures have shown to have beneficial results in patients with grade 2 hallux 
rigidus, yet these two procedures have not been directly compared in clinical trials since the 
invention of the Cartiva. With an estimated revision rate around 9% following Cheilectomy, it is 
possible that Cartiva could decrease the need for additional procedures.  
Specific Aims/Study Objectives:  
 
The major hypothesis of this study is that patient outcomes following Cartiva implantation 
will be non-inferior to those undergoing cheilectomy for patients with grade 2 hallux rigidus. 
Results will include the FAAM ADL and Sport Subscores, SF-36 scores, Visual analog pain scores and 
peak active dorsiflexion in the 2 patient populations. Additional results will include secondary 

 
 
surgeries and adverse events. These will be evaluated pre-operatively and then post operatively at 
2 weeks, 6 weeks, 3 months, 1 year and 2 year follow up. The 2 year follow up visit will be the 
primary end point of the study.  
 
The primary objective of this study will be to evaluate the Cartiva procedure compared to 
the Cheilectomy with the above stated patient reported outcomes and physical exam measures. 
These two procedures are both indicated for the patient population selected in this study, however 
post-surgical results have never been compared to one another in current literature. The secondary 
objective will be to identify subsets of the study population which may be better suited for one of 
the two procedures. Through statistical analysis, we will attempt to identify patient variables that 
may impact the surgical response. This will allow surgeons to appropriately counsel their patients 
on which procedure they would benefit from.  
Research Designs and Methods:  
 
The study will include patients with grade 2 hallux rigidus using the grading system 
described by Coughlin and Shurnas.8 Inclusion criteria will involve patients older than 18 and less 
than 88 years of age. These patients will have the ability to perform the questionnaires and will 
complete the informed consent process. Exclusion criteria will include patients with the diagnosis 
of gout or inflammatory arthropathy, those with inadequate bone stock of the 1st MTP joint (large 
bone cyst >1 cm, avascular necrosis), allergy to polyvinyl alcohol, anyone who is pregnant, anyone 
unable to commit to follow up appointments and patients with significant medical comorbidities 
that make them unsuitable for elective surgery. Subjects will be identified as having grade 2 hallux 
rigidus during a clinic visit with one of 3 fellowship trained foot and ankle orthopedic surgeons. 
After discussion of operative and non-operative interventions, patients will have the ability to 
decide to pursue surgery. If a patient decides to pursue surgical intervention, they will then be 
informed of the study. No additional subject recruitment will be performed. 
 
Once a patient has agreed to take part in the study and has signed the informed consent, 
we will obtain baseline information from their medical records. This information will include 
gender, age, body mass index (BMI), smoking status, and prior 1st MTP joint procedures. At the 
patient’s initial consultation visit (screening visit), their hallux rigidus grade will be defined by one 
of the 3 fellowship trained foot and ankle orthopedic surgeons based on the grading system from 
Coughlin and Shurnas.8 Patients will then be block randomized, by Department of Orthopedics and 
Rehabilitation statistician, into either one of the two treatment groups.  Blocks will be 4 or 6 
subjects in size to ensure balance in the two treatment arms across the duration of the study. The 
standard of care surgical treatment options are either Cartiva hemiarthoplasty or cheilectomy, and 
are the same for this study. Typically, a surgeon would have an informed discussion with the 
patient, listing the risks and benefits of each procedure and allow the patient to determine which 
procedure they would like to pursue. However, for the purpose and specific aims of this study, 
patients will be randomized into one of the two treatment options. Brief descriptions of the 
procedures are provided below: 
Cartiva hemiarthroplasty: The procedure starts with a small incision over the top of the 1st MTP 
joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving 
approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the 

 
 
metatarsal and a drill is then used to create a site for the implant. The implant is then placed using 
the implant introducer. The incision is then closed and a sterile dressing is placed. 
Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone 
spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then 
cut with a saggital saw. Additional bone spurs are resected. The incision is closed and a sterile 
dressing is placed. 
Primary study data will be collected both pre-operatively at the patient’s initial consultation 
visit and then again at post-operative visits at 2 weeks, 6 weeks, 3 months, 1 year and 2 years. This 
study data will include the following: Active peak dorsiflexion of the first MTP joint, SF-36 score, 
Visual analog pain score (VAS) and FAAM. This will be recorded on the attached Data Collection 
Form at each visit. The VAS will be performed by providing patient’s with a 10 cm line and having 
them mark on the line where they would rate their daily pain in their 1st MTP joint.12 That distance 
from the beginning of the line will then be measured in millimeters to identify the patient’s VAS 
score. The patient’s active peak dorsiflexion will be measured in clinic with a goniometer with the 
patient standing and weight bearing on their operative foot. The Medical Outcomes study Short 
form (SF-36) has been validated and thoroughly tested for a wide range of medical conditions, 
including ankle arthritis, to monitor patient symptoms and responses to treatment.13 The 
questionnaire focuses on both the mental and physical aspects of a certain condition to generate 
composite score. The score provides the opportunity to compare patient outcomes prior to and 
following their surgical intervention, as well as track their progress throughout the recovery 
process. Finally, the Foot and Ankle Ability Measures (FAAM) questionnaire will be collected at the 
above stated time points. This measure has been validated for subjects with foot and ankle 
musculoskeletal disorders. It has also been shown to be more responsive to changes in physical 
functioning than the SF-36 score.13 At each follow up visit, the patient will be evaluated for any 
adverse events. If an adverse event is identified, an adverse event form (attached) will be 
completed. All of the above will apply to the 2 week visit, except for the administration of 
questionnaires/surveys. Additionally, subjects will have incision check, suture removal, and a 
physical completed during this visit. 
 
Following completion by the patient at each clinical visit, the Data Collection Form will be 
stored in the physician’s secured office in a specified folder. Dr. Andrew Brooks will collect the hard 
copy Data Collection Forms and questionnaires and enter them into the Department of 
Orthopedics and Rehabilitation’s REDCap Database. After data entry, the Data Collection Forms will 
then be stored in a secure location through the Department of Orthopedic Surgery research 
division, where it will be held for 7 years.  
 
When it comes to study timeline, a patient will be given the opportunity to enroll in the 
study at their initial consultation visit with one of the three board certified foot and ankle surgeons. 
If a patient has been diagnosed with Grade 2 hallux rigidus and is a surgical candidate, they will be 
given the opportunity to enroll in the study. If the patient desires to participate in the study, data 
will be collected from them at their initial consultation visit as described in the Data Collection 
Form. They will then undergo surgical intervention based on their randomization. Following 
surgery, they will follow up in clinic at 2 weeks, 6 weeks, 3 months and 1 year following surgery. 
These follow up visits are standard of care and would occur regardless of patient participation in 

 
 
the study. At each visit, standard of care radiographs will be taken to evaluate the first MTP joint 
and the VAS, SF-36 and FAAM-ADL and Sports questionnaires will be completed specifically for 
research. The final study visit will be at 2 years post-surgery with final radiographs and 
questionnaires.  
 
 
Screening 
Surgery 
Week 2 
Week 6 
Month 3 
Year 1 
Year 2 
Informed 
Consent 
X 
 
 
 
 
 
 
Demographics 
and 
Medical/Surgical 
History 
X 
 
 
 
 
 
 
Data Collection 
Form 
 
 
X 
X 
X 
X 
X 
Review of 
Imaging 
 
 
X 
X 
X 
X 
X 
Physical Exam 
 
 
X 
X 
X 
X 
X 
   
Data Safety and Monitoring Plan:  
 
As seen in previous literature, both the Cheilectomy and Cartiva hemiarthroplasty 
procedures are relatively low risk. Furthermore, both procedures are indicated for patients with 
Grade 2 Hallux Rigidus. In the study done by Baumhauer et al, 9% of patients in the Cartiva group 
required implant removal and revision to a MTP joint fusion.2 All cases were due to persistent pain 
following Cartiva implant, with no evidence of significant bone loss or implant wear. Additionally, 
all cases of revision were successfully revised to an arthrodesis without complication.2 Additionally, 
there is an estimated 8-10% revision rate following Cheilectomy, with revision to arthrodesis being 
the common procedure.14 For this study, the primary surgeons will use their clinical judgement to 
determine if a patient will require a revision procedure if they have persistent pain following their 
initial surgery.  
 
Andrew Brooks, surgical resident in the Department of Orthopedic Surgery will be 
responsible for the monitoring of this data, under supervision from the PI, Dr. Kurt Rongstad. We 
plan to assess our data and do a primary study evaluation when our enrollment has reached 25% of 
our stated enrollment goal. Unanticipated problems, adverse events, protocol deviations and 
violations will be reported to the IRB within 14 days following. 
  
If, at the point of initial evaluation (25% of targeted enrollment), there is a higher than 
expected complication rate in either treatment arm, the study will be postponed at that time for 
further evaluation and possible discontinuation.  
  
In the case that our initial evaluation shows negative results and occurs prior to a 
continuing review, we will contact the IRB with the information and seek to reevaluate or possible 
discontinue the study.  All study team members have completed relevant training materials, are 
well versed in maintaining clinical integrity and data validity, and will be formally instructed in the 

 
 
proper application of this protocol. Data/images will be evaluated by the PI, Dr. Kurt Rongstad, as 
well as Dr. Ronald Guiao and Dr. Kathryn Williams, study team members. This data will be passed to 
Dr. Andrew Brooks, whereupon it will be stored securely as outlined in the Data and Record 
Keeping section of our protocol." 
 
Statistical Considerations:  
 
The primary hypothesis of the study is to show that long term (2 year) functional outcomes 
for those undergoing Cartiva are no worse than the long term functional outcomes for those 
undergoing Cheilectomy.  The primary outcome is the FAAM – ADL subscore from baseline to 2 
years post-surgery.  The MCID of FAAM-ADL is 8 units and we assume the SD of the difference in 
FAAM – ADL from baseline to 2 years post-surgery is near 17 units.  To have 80% power in a non-
inferiority test under these assumptions, we would need to recruit 57 subjects per group.  For 
those subjects that are lost-to-follow-up or have a subsequent surgery we will impute the missing 2 
year follow-up value in two ways: 1) by LOCF (last observation carried forward) and 2) by mean 2 
year follow-up value for those in the same surgical group.  We will then examine results from both 
method as a sensitivity analysis of our imputation method.   To further, assist in ensuring enough 
patients in each group we will inflate our sample size to 60 per group for a total of 120 patients. 
 
Primary analyses will follow the ITT principle and be based on changes in outcomes from 
baseline to 2 years follow-up between the two randomized groups.  Statistical testing for primary 
analyses will consist of non-inferiority t-tests between the two groups for each numerical outcome.  
Secondary analyses will consist of similar non-inferiority t-tests between the two groups but at 
differing follow-up time points (i.e. 3 months, 6 months, and 12 months).  Rates of secondary 
surgeries will be estimated for each group and 95% Cis will be calculated.  Exploratory comparison 
analyses, including RM-ANOVA and log-rank survival analysis, will be examined as well to see if 
there were statistical differences in the various outcomes between groups.  These analyses 
methods will be applied similarly to the secondary outcomes as well.  For each patient reported 
outcome measure, we will use the Minimal clinically important difference (MCID) for each 
measure. As described above, the MCID for the FAAM-ADL subscore is 8 units. The MCID for the 
FAAM-Sports subscore is 9 units. The MCID for the SF-36 Physical component is estimated at 2 units 
for patients with lower extremity osteoarthritis conditions. The MCID for the VAS was found to be -
8 mm when evaluating patients with foot pain.15 Using these values, we will evaluate non-
inferiority by comparing the changes from pre-operative results to the results at the described time 
points. Non-inferiority will be defined as differences that are less than the MCID between the 
Cartiva and Cheilectomy groups. Furthermore,we will assess whether patient characteristics 
affected the functional results between the two surgical groups by including a patient characteristic 
by group interaction into the statistical models. 
Data and Record Keeping:  
 
The hard copies of the Data Collection Form and questionnaires will be collected in the 
respective clinics of the three fellowship-trained orthopedic surgeons participating in the study. 
Data will be recorded on an SF-36 questionnaire form, an FAAM questionnaire form and a visual 

 
 
analog scale. These questionnaires will be completed by the patient during their clinical visits. The 
questionnaire forms will be stored in their locked offices and collected by Dr. Andrew Brooks every 
month. The data from the questionnaire will then be entered into a secure database. The 
questionnaire forms will be stored in the University of Wisconsin Department of Orthopedic 
Surgery research division offices. It will be held there for 7 years. The Data Collection Form 
attached to this document is an example of the form that the physician will complete at both the 
preoperative and postoperative patient visits.  
 
Any future research wishing to utilize data from this study will need an IRB approved 
protocol, before they can access the data. 
 
 
References 
1.  
Lam A, Chan JJ, Surace MF, Vulcano E. Hallux rigidus: How do I approach it? World J Orthop. 
2017. doi:10.5312/wjo.v8.i5.364 
2.  
Baumhauer JF, Singh D, Glazebrook M, et al. Prospective, Randomized, Multi-centered 
Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First 
Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus. Foot Ankle Int. 2015. 
doi:10.1177/1071100716635560 
3.  
Nicolosi N, Hehemann C, Connors J, Boike A. Long-Term Follow-Up of the Cheilectomy for 
Degenerative Joint Disease of the First Metatarsophalangeal Joint. J Foot Ankle Surg. 2015. 
doi:10.1053/j.jfas.2014.12.035 
4.  
Gould N, Schneider W, Ashikaga T. Epidemiological Survey of Foot Problems in the 
Continental United States: 1978–1979 ∗. Foot Ankle Int. 1980. 
doi:10.1177/107110078000100104 
5.  
Lucas DE, Hunt KJ. Hallux Rigidus Relevant Anatomy and Pathophysiology. Foot Ankle Clin. 
2015. doi:10.1016/j.fcl.2015.04.001 
6.  
Kunnasegaran R, Thevendran G. Hallux Rigidus Nonoperative Treatment and Orthotics. Foot 
Ankle Clin. 2015. doi:10.1016/j.fcl.2015.04.003 
7.  
Yee G, Lau J. Current Concepts Review: Hallux Rigidus. Foot Ankle Int. 2008. 
doi:10.3113/FAI.2008.0637 
8.  
Coughlin MJ, Shurnas PS. Hallux Rigidus. Grading and Long-Term Results of Operative 
Treatment. J Bone Jt Surg - Ser A. 2003. doi:10.2106/00004623-200311000-00003 
9.  
Sullivan MR. Hallux Rigidus: MTP Implant Arthroplasty. Foot Ankle Clin. 2009. 
doi:10.1016/j.fcl.2008.11.009 
10.  
Chee YH, Clement N, Ahmed I, Thomson CE, Gibson JNA. Functional outcomes following 
ceramic total joint replacement for hallux rigidus. Foot Ankle Surg. 2011. 
doi:10.1016/j.fas.2009.11.005 

 
 
11.  
Daniels TR, Younger ASE, Penner MJ, et al. Midterm Outcomes of Polyvinyl Alcohol Hydrogel 
Hemiarthroplasty of the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot 
Ankle Int. 2017. doi:10.1177/1071100716679979 
12.  
Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths 
and clinical relevance. Scand J Pain. 2016. doi:10.1016/j.sjpain.2016.06.012 
13.  
Madeley NJ, Wing KJ, Topliss C, Penner MJ, Glazebrook MA, Younger AS. Responsiveness 
and Validity of the SF-36, Ankle Osteoarthritis Scale, AOFAS Ankle Hindfoot Score, and Foot 
Function Index in End Stage Ankle Arthritis. Foot Ankle Int. 2012. doi:10.3113/FAI.2012.0057 
14.  
Cullen B, Stern AL, Weinraub G. Rate of Revision After Cheilectomy Versus Decompression 
Osteotomy in Early-Stage Hallux Rigidus. J Foot Ankle Surg. 2017. 
doi:10.1053/j.jfas.2017.01.038 
15.  
Landorf KB, Radford JA, Hudson S. Minimal Important Difference (MID) of two commonly 
used outcome measures for foot problems. J Foot Ankle Res. 2010. doi:10.1186/1757-1146-
3-7 
 
Data Collection Form  
Study ID: __________ 
Pre-operative Or Post-Operative Visit (How many weeks post op?): _______ 
Hallux Rigidus Grade: ______ 
 
FAAM-Sports Score: ______ 
 
FAAM-ADL Score:_____  
 
VAS Score: ______ 
 
SF-36 Score: _______ 
1st MTP Peak Active Dorsiflexion: ______  
 
Pre-Operative Use Only  
Gender: _______ 
BMI: _______  

 
 
 
# of Previous 1st MTP Procedures: _________ 
Current Smoker (Y/N): _______ 
 
Post-Operative Use Only  
Evidence of Radiographic Implant Loosening (Y/N): ______ 
 
Evidence of Radiographic Osteolysis (Y/N): ______ 
 
Indication for Revision Procedure (Y/N): ________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
Adverse Event Form:  
 
Study ID: __________ 
Date of AE: ________ 
 
Title of AE:  
 
 
Summary of AE:  
 
 
 
 
 
 
 

 
 
Current Status of AE (Resolved, ongoing):  
 
 
 
 
 
 
Action Taken Regarding AE:  
 
 
FAAM Questionnaire 
Please Answer every question with one response that most closely describes your 
condition within the past week. 
If the activity in question is limited by something other than your foot or ankle mark “Not 
Applicable” (N/A). 
No 
Difficulty 
Slight 
Difficulty 
Moderate 
Difficulty 
Extreme 
Difficulty 
Unable 
to do 
N/A 
Standing 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking on even 
Ground 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking on even ground 
without shoes 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking up hills 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking down hills 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Going up stairs 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Going down stairs 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking on uneven ground 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Stepping up and down curbs ∆ 
∆ 
∆ 
∆ 
∆ 
∆ 

 
 
Squatting 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Coming up on your toes 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking initially 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking 5 minutes or less 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking approximately 
10 minutes 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Walking 15 minutes or 
greater 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 

 
 
Page 2 
 
 
Because of your foot and ankle how much difficulty do you have with: 
 
No 
Difficulty 
at all 
Slight 
Difficulty 
Moderate 
Difficulty 
Extreme 
Difficulty 
Unable 
to do 
N/A 
Home responsibilities 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Activities of daily living 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Personal care 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Light to moderate work 
(standing, walking) 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Heavy work 
(push/pulling, 
climbing, carrying) 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Recreational activities 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
 
 
How would you rate your current level of function during you usual activities of daily 
living from 0 to 100 with 100 being your level of function prior to your foot or ankle 
problem and 0 being the inability to perform any of your usual daily activities. 
 
                . 0 % 
 
 
 
 
Martin, R; Irrgang, J; Burdett, R; Conti, S; VanSwearingen, J: Evidence of Validity for the Foot and Ankle Ability Measure. Foot and 
Ankle International. Vol.26, No.11: 968-983, 2005. 

 
 
 
Because of your foot and ankle how much difficulty do you have with: 
 
 
No 
Difficulty 
at all 
Slight 
Difficulty 
Moderate 
Difficulty 
Extreme 
Difficulty 
Unable 
to do 
N/A 
Running 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
 
Jumping 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Landing 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Starting and 
stopping quickly 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Cutting/lateral 
Movements 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Ability to perform 
Activity with your 
Normal technique 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
Ability to participate 
In your desired sport 
As long as you like 
∆ 
∆ 
∆ 
∆ 
∆ 
∆ 
 
 
How would you rate your current level of function during your sports related activities from 0 to 100 with 100 
being your level of function prior to your foot or ankle problem and 0 being the inability to perform any of your 
usual daily activities? 
 
 
               . 0% 
 
 
Overall, how would you rate your current level of function? 
 
 Normal 
∆ Nearly Normal 
∆ Abnormal 
∆ Severely Abnormal 
 
Martin, R; Irrgang, J; Burdett, R; Conti, S; VanSwearingen, J: Evidence of Validity for the Foot and Ankle Ability Measure. Foot and Ankle International. Vol.26, No.11: 
968-983, 2005. 
 
 
 
 
 

 
 
36- Item Short Form Survey Instrument 
(SF-36) 
RAND 36-Item Health Survey 1.0 Questionnaire Items 
Choose one option for each questionnaire item. 
 
1. In general, would you say your health is: 
  1 - Excellent 
  2 - Very good 
  3 - Good 
  4 - Fair 
  5 - Poor 
 
 
2. Compared to one year ago, how would you rate your health in general now? 
  1 - Much better now than one year ago 
  2 - Somewhat better now than one year ago 
  3 - About the same 
  4 - Somewhat worse now than one year ago 
5 - Much worse now than one year ago 
 

 
 
The following items are about activities you might do during a typical day. Does your 
health now limit you in these activities? If so, how much? 
 
Yes, 
limited a 
lot 
Yes, 
limited a 
little 
No, not 
limited at 
all 
3. Vigorous activities, such as running, lifting heavy objects, 
participating in strenuous sports 
  1 
  2 
  3 
4. Moderate activities, such as moving a table, pushing a 
vacuum cleaner, bowling, or playing golf 
  1 
  2 
  3 
5. Lifting or carrying groceries 
  1 
  2 
  3 
6. Climbing several flights of stairs 
  1 
  2 
  3 
7. Climbing one flight of stairs 
  1 
  2 
  3 
8. Bending, kneeling, or  stooping 
  1 
  2 
  3 
9. Walking more than a mile 
  1 
  2 
  3 
10. Walking several blocks 
  1 
  2 
  3 
11. Walking one block 
  1 
  2 
  3 
12. Bathing or dressing  yourself 
1 
2 
3 
 
 

 
 
During the past 4 weeks, have you had any of the following problems with your work or other 
regular daily activities as a result of your physical health? 
 
 
13. Cut down the amount of time you spent on work or other activities 
 
14. Accomplished less than you would like 
 
15. Were limited in the kind of work or other activities 
 
16. Had difficulty performing the work or other activities (for example, it took extra 
effort) 
 
Yes 
No 
 
 
 
1 
2 
 
 
 
1 
2 
 
 
 
1 
2

 
 
 
 
 
 
During the past 4 weeks, have you had any of the following problems with your work or other 
regular daily activities as a result of any emotional problems (such as feeling depressed 
or anxious)? 
Yes 
No 
17. Cut down the amount of  time you spent on work or other activities 
  1 
  2 
 
18. Accomplished less than you would like 
  1 
  2 
 
19. Didn't do work or other activities as carefully as usual 
  1 
  2 
 
 
 
20. During the past 4 weeks, to what extent has your physical health or emotional 
problems interfered with your normal social activities with family, friends, neighbors, or 
groups? 
  1 - Not at all 
  2 - Slightly 
  3 - Moderately 
  4 - Quite a bit 
5 - Extremely 
 
21. How much bodily pain have you had during the past 4 weeks? 
  1 - None 
  2 - Very mild 
  3 - Mild 
  4 - Moderate 
  5 - Severe 
  6 - Very severe 

 
 
 
 
22. During the past 4 weeks, how much did pain interfere with your normal work 
(including both work outside the home and housework)? 
  1 - Not at all 
  2 - A little bit 
  3 - Moderately 
  4 - Quite a bit 
5 - Extremely

 
 
These questions are about how you feel and how things have been with you during the 
past 4 weeks. For each question, please give the one answer that comes closest to the way 
you have been feeling. 
How much of the time during the past 4 weeks... 
 
All of 
Most 
A good 
Some 
A little 
None 
the 
of the 
bit of the 
of the 
of the 
of the 
time 
time 
time 
time 
time 
time 
23. Did you feel full of pep? 
  1 
  2 
  3 
  4 
  5 
  6 
24. Have you been a very nervous 
person? 
  1 
  2 
  3 
  4 
  5 
  6 
25. Have you felt so down in the 
dumps that nothing could cheer you 
up? 
  1 
  2 
  3 
  4 
  5 
  6 
26. Have you felt calm and peaceful? 
  1 
  2 
  3 
  4 
  5 
  6 
27. Did you have a lot of energy? 
  1 
  2 
  3 
  4 
  5 
  6 
28. Have you felt downhearted and 
blue? 
  1 
  2 
  3 
  4 
  5 
  6 
29. Did you feel worn out? 
  1 
  2 
  3 
  4 
  5 
  6 
30. Have you been a happy person? 
  1 
  2 
  3 
  4 
  5 
  6 
31. Did you feel tired? 
1 
2 
3 
4 
5 
6 
 
 
 
32. During the past 4 weeks, how much of the time has your physical health or emotional 
problems interfered with your social activities (like visiting with friends, relatives, etc.)? 
         1 - All of the time   
  2 - Most of the time     
  3 - Some of the time 
 4 - A little of the time  
 5 - None of the time

 
 
How TRUE or FALSE is each of the following statements for you. 
 
Definitely 
true 
Mostly 
true 
Don't 
know 
Mostly 
false 
Definitely 
false 
33. I seem to get sick a little easier than 
other people 
  1 
  2 
  3 
  4 
  5 
34. I am as healthy as anybody I know 
  1 
  2 
  3 
  4 
  5 
35. I expect my health to get worse 
  1 
  2 
  3 
  4 
  5 
36. My health is excellent 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
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