A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus
| Registry | NCT01048450 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, factorial, masking: none, treatment |
| Enrollment | 158 (Actual) |
| Sponsor | American College of Foot and Ankle Surgeons (Other) |
| Conditions | Hallux Limitus, Hallux Rigidus |
| Interventions | Joint Resection- Keller Procedure, Joint Fusion, Hemi-metallic Joint Implant (Radiation, procedure) |
| Dates | start 2009-07-01, primary completion 2011-06-01, completion 2011-06-01, first posted 2010-01-13, last updated 2011-08-19 |
| Locations | 6 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Hallux Limitus All trials for Hallux Rigidus All trials of Joint Resection- Keller Procedure All trials of Joint Fusion
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment | Experimental | Radiation: Joint Resection- Keller Procedure; Procedure: Joint Fusion; Procedure: Hemi-metallic Joint Implant | Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint) |
Sex: All, ages: 21 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |