Surgical Treatment for Hallux Rigidus

Hallux Rigidus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048450
• Other study ID #: 0709-1
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: August 17, 2011
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2010
• Source: American College of Foot and Ankle Surgeons
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

Radiation:
• Joint Resection- Keller Procedure
These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux

Procedure:
• Joint Fusion
Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.
• Hemi-metallic Joint Implant
Those who had a surgical procedure of a hemi-metallic joint implant

Locations

Country	Name	City	State
United States	Capitol Orthopaedics & SPorts Medicine	Des Moines	Iowa
United States	Foot & Ankle Center of Northern Colorado	Greeley	Colorado
United States	Scituate Podiatry Group	Scituate	Massachusetts
United States	Marc Kravettte	Seattle	Washington
United States	Michigan Foot & Ankle Center	Southfield	Michigan
United States	Ankle and Foot Care Centers	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
American College of Foot and Ankle Surgeons

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gibson JN, Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot Ankle Int. 2005 Sep;26(9):680-90. — View Citation

Raikin SM, Ahmad J. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. Surgical technique. J Bone Joint Surg Am. 2008 Oct;90 Suppl 2 Pt 2:171-80. doi: 10.2106/JBJS.H.00368. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective: pain, function, alignment		At least 1 year after surgical intervention	No
Secondary	Frequency and types of undesired effects		At least 1 year after surgical intervention	No
Secondary	Demographic data and trends		At least 1 year after surgical intervention	No

External Links

•   Sponsor's Web site