Surgical Treatment for Hallux Rigidus

American College of Foot and Ankle Surgeons

Status: Completed

Conditions: Hallux Rigidus; Hallux Limitus

Treatments: Procedure: Hemi-metallic Joint Implant; Radiation: Joint Resection- Keller Procedure; Procedure: Joint Fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01048450

0709-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

158 participants in 1 patient group

Treatment

Experimental group

Description:

Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)

Treatment:

Procedure: Joint Fusion

Radiation: Joint Resection- Keller Procedure

Procedure: Hemi-metallic Joint Implant