Surgical Treatment for Hallux Rigidus

A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01048450

Enrollment

158

Registered

2010-01-13

Start date

2009-07-31

Completion date

2011-06-30

Last updated

2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Limitus, Hallux Rigidus

Keywords

arthritis, degeneration

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.

Interventions

RADIATIONJoint Resection- Keller Procedure

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

PROCEDUREJoint Fusion

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

PROCEDUREHemi-metallic Joint Implant

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Subjective: pain, function, alignment	At least 1 year after surgical intervention

Secondary

Measure	Time frame
Frequency and types of undesired effects	At least 1 year after surgical intervention
Demographic data and trends	At least 1 year after surgical intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026