Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

Not Applicable

Completed

• Conditions: Lesser Toe Deformity; Claw Toe
• Interventions: Procedure: Arthrodesis; Procedure: Resection arthroplasty

• Registration Number: NCT03530839
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Study First Submitted: 2018-04-25
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthrodesis	Arthrodesis	Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire
Resection arthroplasty	Resection arthroplasty	Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire

Primary Outcome Measures

Name	Time	Method
Pain	Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively	Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
Function	Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively	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))

Secondary Outcome Measures

Name	Time	Method
Osseous consolidation	6months postoperatively	Osseous consolidation of the procedure was evaluated using x-rays