A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hallux Limitus
- Sponsor
- American College of Foot and Ankle Surgeons
- Enrollment
- 158
- Locations
- 6
- Primary Endpoint
- Subjective: pain, function, alignment
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •End stage hallux limitus/rigidus
- •Status post 1 year since having the surgery
- •Must have had a joint resection, fusion, or hemi-metallic implant
Exclusion Criteria
- •History of seropositive or seronegative arthritis
- •Have had a primary surgery before then had one of the above surgeries performed
Outcomes
Primary Outcomes
Subjective: pain, function, alignment
Time Frame: At least 1 year after surgical intervention
Secondary Outcomes
- Frequency and types of undesired effects(At least 1 year after surgical intervention)
- Demographic data and trends(At least 1 year after surgical intervention)