NCT01048450

Surgical Treatment for Hallux Rigidus

A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: American College of Foot and Ankle Surgeons · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hallux Limitus
• Hallux Rigidus

Interventions

Type	Name	Description
RADIATION	Joint Resection- Keller Procedure	These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
PROCEDURE	Joint Fusion	Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
PROCEDURE	Hemi-metallic Joint Implant	Those who had a surgical procedure of a hemi-metallic joint implant

Timeline

• Start date: 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 across 1 country: United States