Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT03530839

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Claw Toe Lesser Toe Deformity	Procedure: Arthrodesis Procedure: Resection arthroplasty	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arthrodesis

Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire

Procedure: Arthrodesis

see study group description

Active Comparator: Resection arthroplasty

Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire

Procedure: Resection arthroplasty

see study group description

Outcome Measures

Primary Outcome Measures

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

Osseous consolidation [6months postoperatively]
Osseous consolidation of the procedure was evaluated using x-rays

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.