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A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus
The purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.
Hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (MTPJ). There are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. Patients with end stage arthritis are often given several surgical options for the treatment of the first MTPJ. The procedures are correlated to the patient's age, type of shoe gear, activity level, Body Mass Index, degree of arthritis, desire for joint mobility and bone density. This proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first MTPJ implants. A multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first MTPJ will be evaluated. Subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. Further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. The results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Foot & Ankle Center of Northern Colorado
Greeley, Colorado, United States
Capitol Orthopaedics & SPorts Medicine
Des Moines, Iowa, United States
Scituate Podiatry Group
Scituate, Massachusetts, United States
Michigan Foot & Ankle Center
Southfield, Michigan, United States
Ankle and Foot Care Centers
Youngstown, Ohio, United States
Marc Kravettte
Seattle, Washington, United States
Start Date
July 1, 2009
Primary Completion Date
June 1, 2011
Completion Date
June 1, 2011
Last Updated
August 19, 2011
158
ACTUAL participants
Joint Resection- Keller Procedure
RADIATION
Joint Fusion
PROCEDURE
Hemi-metallic Joint Implant
PROCEDURE
Lead Sponsor
American College of Foot and Ankle Surgeons
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03616847