Clinical trial NCT01048450: Surgical Treatment for Hallux Rigidus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Limitus
Hallux Rigidus
Keywords: arthritis
degeneration
Lead sponsor: American College of Foot and Ankle Surgeons
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 158
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Subjective: pain, function, alignment
timeFrame: At least 1 year after surgical intervention
Secondary outcomes:
measure: Frequency and types of undesired effects
timeFrame: At least 1 year after surgical intervention
measure: Demographic data and trends
timeFrame: At least 1 year after surgical intervention
Other outcomes:
Locations:
city: Greeley
country: United States
facility: Foot & Ankle Center of Northern Colorado
state: Colorado
city: Des Moines
country: United States
facility: Capitol Orthopaedics & SPorts Medicine
state: Iowa
city: Scituate
country: United States
facility: Scituate Podiatry Group
state: Massachusetts
city: Southfield
country: United States
facility: Michigan Foot & Ankle Center
state: Michigan
city: Youngstown
country: United States
facility: Ankle and Foot Care Centers
state: Ohio
city: Seattle
country: United States
facility: Marc Kravettte
state: Washington
Study officials:
affiliation: American College of Foot & Ankle Surgeons
name: Paul J Kim, DPM
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1177/107110070502600904.
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.