Surgical Treatment for Hallux Rigidus

Not Applicable

Completed

• Conditions: Hallux Limitus; Hallux Rigidus
• Interventions: Radiation: Joint Resection- Keller Procedure; Procedure: Joint Fusion; Procedure: Hemi-metallic Joint Implant

• Registration Number: NCT01048450
• Lead Sponsor: American College of Foot and Ankle Surgeons

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.

Study Timeline

• Study Start: 2009-07
• Status Verified: 2010-01
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Treatment	Joint Resection- Keller Procedure	Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Treatment	Joint Fusion	Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Treatment	Hemi-metallic Joint Implant	Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)

Primary Outcome Measures

Name	Time	Method
Subjective: pain, function, alignment	At least 1 year after surgical intervention

Secondary Outcome Measures

Name	Time	Method
Frequency and types of undesired effects	At least 1 year after surgical intervention
Demographic data and trends	At least 1 year after surgical intervention

Trial Locations

Locations (6)

Foot & Ankle Center of Northern Colorado; 🇺🇸 Greeley, Colorado, United States

Michigan Foot & Ankle Center; 🇺🇸 Southfield, Michigan, United States

Ankle and Foot Care Centers; 🇺🇸 Youngstown, Ohio, United States

Scituate Podiatry Group; 🇺🇸 Scituate, Massachusetts, United States

Capitol Orthopaedics & SPorts Medicine; 🇺🇸 Des Moines, Iowa, United States

Marc Kravettte; 🇺🇸 Seattle, Washington, United States