Comparing Ankle Fusion to Ankle Replacement
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 21 - 89 |
| Updated: | 9/12/2018 |
| Start Date: | May 2012 |
| End Date: | May 2027 |
Comparing Ankle Arthrodesis to Ankle Arthroplasty
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.
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.
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.
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.
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
We found this trial at
6
sites
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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