Treatment Outcomes for Ankle Arthritis

NCT00391365 | Completed Results

• 1 other identifier: F4513-R
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine any functional outcome differences in patients who have undergone surgical treatment for ankle osteoarthritis using surveys, step counts, and laboratory gait analysis. This study is closed to recruitment; follow-up procedures are completed; the study remains open for data analysis. Enrollment was completed by August 2012. As of July 2016, the study is currently analyzing data. In April 2017 the study was approved to begin long term follow-up with study participants. Study personnel contact participants via telephone and/or U.S. Mail to tell them about long term follow-up, and to ask whether they are willing to continue study participation. Long term follow-up will be for up to 12 years after the participant's ankle surgery.

Conditions

Osteoarthritis

Keywords

ankle osteoarthritis; arthritis; arthrodesis; arthroplasty; Gait; step count; walking

Outcome Measures

Primary Outcomes (1)

• Musculoskeletal Functional Assessment (MFA)

  Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items. Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.)

  Over the course of 3 years

Secondary Outcomes (2)

• Physical Function Section of Short Form-36 (SF-36)

  Over the course of 3 years.

• Bodily Pain Section of Short Form-36 (SF-36)

  Over the course of 3 years.

Study Arms (2)

Group 1

Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis

Procedure: Gait analysis

Group 2

Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis

Procedure: Gait analysis

Interventions

Gait analysis PROCEDURE

Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with ankle osteoarthritis who will undergo either ankle arthrodesis (fusion) or ankle arthroplasty (replacement)

You may qualify if:

• Ankle arthritis subjects will be recruited from patients at
• VA Puget Sound Health Care System (Seattle, WA)
• Harborview Medical Center (Seattle, WA)
• Orthopaedic Associates of Michigan (Grand Rapids, MI)
• Orthopedic + Fracture Specialists (Portland, OR)
• Twin Cities Orthopedics (Edina, MN)
• who have been diagnosed with end stage ankle arthrosis
• are ambulatory
• speak English
• are cognitively intact
• between the ages of 18-89
• and have elected to undergo surgical correction (arthrodesis or arthroplasty) for end-stage ankle arthritis

You may not qualify if:

• Suffer from Rheumatoid Arthritis or other systemic arthritis
• Have any other diseased lower extremity joints or traumatic lower extremity injury that grossly inhibits normal gait

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Orthopaedic Associates of Michigan (Grand Rapids, MI): collaborator
• Orthopedic + Fracture Specialists, Portland, OR: collaborator
• Minnesota Orthopedic Sports Medicine Institute Twin Cities Orthopedics (Edina, MN): collaborator

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

• Segal AD, Cyr KM, Stender CJ, Whittaker EC, Hahn ME, Orendurff MS, Ledoux WR, Sangeorzan BJ. A three-year prospective comparative gait study between patients with ankle arthrodesis and arthroplasty. Clin Biomech (Bristol). 2018 May;54:42-53. doi: 10.1016/j.clinbiomech.2018.02.018. Epub 2018 Mar 5.

  PMID: 29550642 DERIVED

Biospecimen

Retention: NONE RETAINED

No biospecimens are used in this project

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Ankylosis

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Limitations and Caveats

This study was not randomized, and no chart review was conducted.

Results Point of Contact

• Title: Alan Wesley, Program Manager
• Organization: Center For Limb Loss Prevention and Prosthetic Engineering, VA Puget Sound Health Care System

alan.wesley@va.gov

206 277 1079

Study Officials

• Bruce J. Sangeorzan, MD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 24, 2006
• Study Start: March 1, 2005
• Primary Completion: August 1, 2015
• Study Completion: December 31, 2025
• Last Updated: January 26, 2026
• Results First Posted: December 21, 2016

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)