Surgical Treatment for Hallux Rigidus

Study Overview
=================
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.

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

Conditions
-----------------
Hallux Limitus, Hallux Rigidus

Intervention / Treatment
-----------------
* Radiation: Joint Resection- Keller Procedure
* Procedure: Joint Fusion
* Procedure: Hemi-metallic Joint Implant


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Those who were diagnosed with hallux limitus/rigidus (end stage degeneration at the 1st metatarsal phalangeal joint) | Radiation: Joint Resection- Keller Procedure<br>* These subjects had received a surgical intervention of removing the proximal portion of the proximal phalanx of the hallux<br>* Other names: Keller Arthoplasty;Procedure: Joint Fusion<br>* Those who had a surgical intervention of fusion of the 1st metatarsal phalangeal joint.<br>* Other names: Arthrodesis;Procedure: Hemi-metallic Joint Implant<br>* Those who had a surgical procedure of a hemi-metallic joint implant<br>* Other names: Joint Implant;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective: pain, function, alignment |  | At least 1 year after surgical intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis, degeneration