Clinical Trial: Surgical Treatment for Hallux Rigidus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: American College of Foot and Ankle Surgeons

Current Primary Outcome: Subjective: pain, function, alignment [ Time Frame: At least 1 year after surgical intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency and types of undesired effects [ Time Frame: At least 1 year after surgical intervention ]
  • Demographic data and trends [ Time Frame: At least 1 year after surgical intervention ]


Original Secondary Outcome: Same as current

Information By: American College of Foot and Ankle Surgeons

Dates:
Date Received: January 11, 2010
Date Started: July 2009
Date Completion:
Last Updated: August 17, 2011
Last Verified: January 2010