N/A N=273

Treatment Outcomes for Ankle Arthritis

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00391365 ↗

Enrolled (actual)

273

Serious AEs

—

Results posted

Dec 2016

Primary outcome: Primary: Musculoskeletal Functional Assessment (MFA) — -12.5; -15.0 units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Gait analysis (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Musculoskeletal Functional Assessment (MFA)	-12.5; -15.0	—
SECONDARY Physical Function Section of Short Form-36 (SF-36)	25.4; 31.8	—
SECONDARY Bodily Pain Section of Short Form-36 (SF-36)	35.3; 34.8	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00391365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.