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Surgical Treatment for Hallux Rigidus

This study has been completed.
Sponsor:
Information provided by:
American College of Foot and Ankle Surgeons
ClinicalTrials.gov Identifier:
NCT01048450
First received: January 11, 2010
Last updated: August 17, 2011
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Hallux Limitus
Hallux Rigidus
 Radiation: Joint Resection- Keller Procedure
Procedure: Joint Fusion
Procedure: Hemi-metallic Joint Implant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by American College of Foot and Ankle Surgeons:

Primary Outcome Measures:
  • Subjective: pain, function, alignment [ Time Frame: At least 1 year after surgical intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and types of undesired effects [ Time Frame: At least 1 year after surgical intervention ] [ Designated as safety issue: No ]
  • Demographic data and trends [ Time Frame: At least 1 year after surgical intervention ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Keller Arthoplasty
Procedure: Joint Fusion
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
Other Name: Arthrodesis
Procedure: Hemi-metallic Joint Implant
Those who had a surgical procedure of a hemi-metallic joint implant
Other Name: Joint Implant

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048450

Locations
United States, Colorado
Foot & Ankle Center of Northern Colorado
Greeley, Colorado, United States, 80634
United States, Iowa
Capitol Orthopaedics & SPorts Medicine
Des Moines, Iowa, United States, 50325
United States, Massachusetts
Scituate Podiatry Group
Scituate, Massachusetts, United States, 02066
United States, Michigan
Michigan Foot & Ankle Center
Southfield, Michigan, United States, 48034
United States, Ohio
Ankle and Foot Care Centers
Youngstown, Ohio, United States, 44512
United States, Washington
Marc Kravettte
Seattle, Washington, United States, 98101
Sponsors and Collaborators
American College of Foot and Ankle Surgeons
Investigators
Study Director: Paul J Kim, DPM American College of Foot & Ankle Surgeons
  More Information

Additional Information:
Sponsor's Web site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Paul J Kim, DPM, FACFAS, Associate Professor, American College of Foot and Ankle Surgeons
ClinicalTrials.gov Identifier: NCT01048450     History of Changes
Other Study ID Numbers: 0709-1
Study First Received: January 11, 2010
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Foot and Ankle Surgeons:
arthritis
degeneration

Additional relevant MeSH terms:
Hallux Rigidus
Hallux Limitus
Foot Deformities, Acquired
 Foot Deformities
Musculoskeletal Diseases
Joint Diseases

ClinicalTrials.gov processed this record on May 22, 2013