Surgical Treatment for Hallux Rigidus

NCT ID: NCT01048450

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Hallux Limitus Hallux Rigidus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint)

Group Type EXPERIMENTAL

Joint Resection- Keller Procedure

Intervention Type RADIATION

These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux

Joint Fusion

Intervention Type PROCEDURE

Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.

Hemi-metallic Joint Implant

Intervention Type PROCEDURE

Those who had a surgical procedure of a hemi-metallic joint implant

Interventions

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Joint Resection- Keller Procedure

These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux

Intervention Type RADIATION

Joint Fusion

Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.

Intervention Type PROCEDURE

Hemi-metallic Joint Implant

Those who had a surgical procedure of a hemi-metallic joint implant

Intervention Type PROCEDURE

Other Intervention Names

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Keller Arthoplasty Arthrodesis Joint Implant

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Foot and Ankle Surgeons

OTHER

Sponsor Role lead

Responsible Party

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American College of Foot and Ankle Surgeons

Principal Investigators

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Paul J Kim, DPM

Role: STUDY_DIRECTOR

American College of Foot & Ankle Surgeons

Locations

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Foot & Ankle Center of Northern Colorado

Greeley, Colorado, United States

Site Status

Capitol Orthopaedics & SPorts Medicine

Des Moines, Iowa, United States

Site Status

Scituate Podiatry Group

Scituate, Massachusetts, United States

Site Status

Michigan Foot & Ankle Center

Southfield, Michigan, United States

Site Status

Ankle and Foot Care Centers

Youngstown, Ohio, United States

Site Status

Marc Kravettte

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16174497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18829931 (View on PubMed)

Related Links

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http://www.acfas.org

Sponsor's Web site

Other Identifiers

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0709-1

Identifier Type: -

Identifier Source: org_study_id

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