End-stage Ankle Arthritis (ESAA), Osteoarthritis (OA)
Conditions
Brief summary
End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain, dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking for even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have two primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two procedures, and no randomized controlled trials (RCTs) have been performed. The investigators will compare the following in subjects undergoing ankle arthrodesis and ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years. 1. Overall physical function and ankle specific function 2. Ankle pain intensity and interference with activities 3. Activity levels 4. Overall general health 5. Post-surgical complication rates The investigators will also identify prognostic factors that are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction.
Detailed description
From study inception until March 2014, the investigators conducted a multi-site randomized controlled trial (RCT) comparing the effectiveness of ankle arthrodesis and ankle arthroplasty over a 2-year follow-up period. The study used a modified Comprehensive Cohort Design. Subjects unwilling to randomize to surgery could still participate in the study by entering into the preference cohort and select surgery in consultation with their surgeon. By March 2014, no subjects had entered into the randomized cohort. The Data and Safety Monitoring Board (DSMB) recommended stopping recruitment in the randomized arm of the study since no subjects were willing to randomize to surgery. All patients were enrolled in the preference cohort and selected arthrodesis or arthroplasty. Despite the change in study design, the objectives remain unchanged.
Interventions
PROCEDUREAnkle Arthrodesis
All surgeons will employ a well-established technique of rigid internal fixation. In this technique, the joint is prepared by removing cartilage from the surfaces, the bones are positioned as desired, and screws and/or a plate are attached to compress the bones together and prevent motion. This technique obviates the need for a cast or external support. Patients are allowed to walk with weight bearing aids immediately. Radiographs are performed at 6 weeks to determine weight bearing status. Weight is allowed on the limb in increments over the 6 to 12 weeks after surgery.
PROCEDUREAnkle Arthroplasty
Protocols are similar among participating centers. Each surgeon uses an anterior surgical approach between the tibialis anterior tendon and the toe extensor group, splints the ankles for 2 weeks, and restricts weight bearing for the first 6 weeks. Radiographs are performed at 6 weeks to determine weight bearing status. The study involves only FDA approved implants with which the surgeon has established experience.
Sponsors
Seattle Institute for Biomedical and Clinical Research
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
University of Washington
Orthopedic + Fracture Specialists, Portland, OR
Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics
Orthopaedic and Spine Center of the Rockies
Orthopaedic Associates of Michigan, PC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of ankle arthritis 2. Failed conservative care and deemed a surgical candidate 3. Adult patients between 21 and 89 years of age 4. Ambulatory but whose primary impediment to pain-free ambulation is ankle arthritis
Exclusion criteria
1. Recent surgical, neurological, metabolic, or lower limb musculoskeletal problem that might impair the ambulation measures in the study such as severe knee or hip osteoarthritis 2. Complicated procedures requiring multiple corrections 3. Inflammatory arthritis with multi-focal disease (i.e. arthritis that affects multiple parts of the body) 4. Inadequate cognitive or language function to consent to participate 5. Unable or unwilling to participate in clinic follow-ups and/or remote follow-ups for 24 months after surgery 6. Unwilling or unable to comply with postoperative management program 7. Lack of a telephone number or stable mailing address
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty | Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op | Ankle specific function was assessed using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale, a validated, self-reported questionnaire which measures functional ability during activities of daily living. \[CH1.1\]The FAAM ADL subscale sums and coverts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function. |
| Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty | Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op | Ankle specific function during sports activities was measured using the Foot and Ankle Ability Measure (FAAM) Sports subscale, a validated, self-reported questionnaire which measures functional ability during sport-related activities. The FAAM Sports subscale sums and converts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function during sports activities. |
| Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty | Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op | Ankle specific function was assessed using the Short Form-36 (SF-36) Physical Component Summary (PCS) score, a validated, generic measure of health-related quality of life that evaluates physical health status. The PCS score is derived from responses to the SF-36 questionnaire and is norm-based, with scores ranging from 0-100, where higher scores indicate better physical health and lower scores indicate poorer physical health. |
| Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain) | Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op | Pain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of worst pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be") |
| Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain) | Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op | Pain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of average ankle pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be") |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical Complication Rates | Assessed monthly until 12 months after surgery | Ankle-specific complications in the 12-month period post surgery |
| Change in Daily Step Counts | Before surgery and at 6, 12, and 24 months after surgery | Step counts using a StepWatch Activity Monitor, worn for a 7-14 day time period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBruce J Sangeorzan, MD
VA Puget Sound Health Care System & University of Washington
Participant flow
Pre-assignment details
Protocol Enrollment should be 517
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age +/- (yr) | 54.2 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 503 Participants |
| Sex/Gender, Customized Female | 42 Participants |
| Sex/Gender, Customized Male | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 414 |
| other Total, other adverse events | 13 / 103 | 26 / 414 |
| serious Total, serious adverse events | 4 / 103 | 7 / 414 |
Outcome results
None listed