Comparing Ankle Fusion to Ankle Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Seattle Institute for Biomedical and Clinical Research
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT01620541
First received: June 11, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 at 3, 6, 12 and 24 months after surgery:

  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.


Condition Intervention
End-stage Ankle Arthritis (ESAA)
Osteoarthritis (OA)
Procedure: Ankle Arthrodesis
Procedure: Ankle Arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing Ankle Arthrodesis to Ankle Arthroplasty

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Change in overall physical function and ankle specific function between subjects undergoing ankle arthrodesis and total ankle arthroplasty [ Time Frame: Before surgery and 3, 6, 12, and 24 months after surgery ] [ Designated as safety issue: No ]
    Questionnaire data (Foot and Ankle Ability Measure; SF-36 Health Survey)

  • Change in overall pain intensity and ankle specific pain intensity; Interference with activities in subjects undergoing ankle arthrodesis and total ankle arthroplasty [ Time Frame: Before surgery and 3, 6, 12, and 24 months after surgery ] [ Designated as safety issue: No ]
    Questionnaire data (Foot and Ankle Ability Measure; Chronic Pain Grade)

  • Change in general health in subjects undergoing ankle arthrodesis and total ankle arthroplasty [ Time Frame: Before surgery and 3, 6, 12, and 24 months after surgery ] [ Designated as safety issue: No ]
    Questionnaire data (Functional Comorbidity Index and SF-36 Health Survey)


Secondary Outcome Measures:
  • Intrinsic and extrinsic prognostic factors which are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction [ Time Frame: Assessed before surgery and 3, 6, 12, and 24 months after surgery ] [ Designated as safety issue: Yes ]
    Medical record review and questionnaire data

  • Post-surgical complication rates [ Time Frame: Assessed monthly until 24 months after surgery ] [ Designated as safety issue: Yes ]
    Medical record review

  • Change in daily step counts [ Time Frame: Before surgery and at 6, 12, and 24 months after surgery ] [ Designated as safety issue: No ]
    Step counts using a StepWatch Activity Monitor, worn for a 7-14 day time period.

  • Change in patient satisfaction [ Time Frame: 3, 6, 12, and 24 months after surgery ] [ Designated as safety issue: No ]
    Questionnaire data


Estimated Enrollment: 512
Study Start Date: May 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preference, Ankle Arthrodesis Procedure: Ankle 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.
Preference, Ankle Arthroplasty Procedure: Ankle 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.

Detailed Description:

From study inception until March 2014, the investigators conducted a multi-site 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. The study is no longer a RCT but remains open to enrollment. All patients are enrolled in the preference cohort and select arthrodesis or arthroplasty. Despite the change in study design, the objectives remain unchanged.

  Eligibility

Ages Eligible for Study:   21 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects are recruited from surgical foot and ankle orthopedic clinics at the participating study sites.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620541

Contacts
Contact: Marisa R Benich, BS 206-277-1079
Contact: Bruce J. Sangeorzan, MD 206-277-3223

Locations
United States, Colorado
Orthopaedic and Spine Center of the Rockies Recruiting
Fort Collins, Colorado, United States, 80525
Contact: Amber M Curtis, ACNP-C    970-493-0112      
Contact: Michael Bergerson, MBA    970-419-7006      
Principal Investigator: Michael Houghton, MD         
United States, Michigan
Orthopaedic Associates of Michigan Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Michelle A Padley, BS    616-459-7101 ext 797      
Principal Investigator: John G Anderson, MD         
Sub-Investigator: Donald R Bohay, MD         
Sub-Investigator: John D Maskill, MD         
United States, Minnesota
Twin Cities Orthopedics Recruiting
Edina, Minnesota, United States, 55435
Contact: Becky Stone, MS, ATC    952-456-7136      
Principal Investigator: J. Christiaan Coetzee, MD         
United States, Oregon
Orthopedic + Fracture Specialists Recruiting
Portland, Oregon, United States, 97225
Contact: Debra Brovelli, CCRP    503-214-5259      
Principal Investigator: James Davitt, MD         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Marisa R Benich, BS    206-277-1079      
Principal Investigator: Bruce J Sangeorzan, MD         
Sub-Investigator: William R Ledoux, PhD         
VA Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Marisa R Benich, BS    206-277-1079      
Principal Investigator: Bruce J Sangeorzan, MD         
Sub-Investigator: William R Ledoux, PhD         
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
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
Investigators
Principal Investigator: Bruce J Sangeorzan, MD VA Puget Sound Health Care System & University of Washington
  More Information

No publications provided

Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT01620541     History of Changes
Other Study ID Numbers: SB223, 1R01AR056316-01A2
Study First Received: June 11, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014