Surgical Treatment for Hallux Rigidus

August 17, 2011 updated by: American College of Foot and Ankle Surgeons

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Greeley, Colorado, United States, 80634
        • Foot & Ankle Center of Northern Colorado
    • Iowa
      • Des Moines, Iowa, United States, 50325
        • Capitol Orthopaedics & SPorts Medicine
    • Massachusetts
      • Scituate, Massachusetts, United States, 02066
        • Scituate Podiatry Group
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Michigan Foot & Ankle Center
    • Ohio
      • Youngstown, Ohio, United States, 44512
        • Ankle and Foot Care Centers
    • Washington
      • Seattle, Washington, United States, 98101
        • Marc Kravettte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)
Radiation: Joint Resection- Keller Procedure
These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux
Other Names:
  • Keller Arthoplasty
Procedure: Joint Fusion
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
Other Names:
  • Arthrodesis
Procedure: Hemi-metallic Joint Implant
Those who had a surgical procedure of a hemi-metallic joint implant
Other Names:
  • Joint Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subjective: pain, function, alignment
Time Frame: At least 1 year after surgical intervention
At least 1 year after surgical intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and types of undesired effects
Time Frame: At least 1 year after surgical intervention
At least 1 year after surgical intervention
Demographic data and trends
Time Frame: At least 1 year after surgical intervention
At least 1 year after surgical intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Foot and Ankle Surgeons

Investigators

  • Study Director: Paul J Kim, DPM, American College of Foot & Ankle Surgeons

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0709-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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