Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

Study Overview
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Brief Summary
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Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty. Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months postoperatively.

Official Title
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Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study

Conditions
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Claw Toe, Lesser Toe Deformity

Intervention / Treatment
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* Procedure: Arthrodesis
* Procedure: Resection arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department Exclusion Criteria: known osteoporosis or other bone metabolism disorders prior surgery on the toe scheduled for the intervention immunodeficiency or immunosuppressive drug intake pregnancy non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery anticoagulation therapy with the exception of acetylsalicylic acid a lack of sufficient physical resilience to allow free self-mobilization and walking.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthrodesis<br>Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire | Procedure: Arthrodesis<br>* see study group description<br>|
| Active Comparator: Resection arthroplasty<br>Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire | Procedure: Resection arthroplasty<br>* see study group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain)) | Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively | 
| Function | Change in function was evaluated using the American Orthopaedic Foot and Ankle Society score (ranging from 0 (severe impairment) to 100 (no problems with foot)) | Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osseous consolidation | Osseous consolidation of the procedure was evaluated using x-rays | 6months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lesser toe deformity, claw toe, PIP joint, arthrodesis, resection arthroplasty