Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Claw Toe; Lesser Toe Deformity
• Intervention / Treatment: Procedure: Arthrodesis; Procedure: Resection arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: PIP joint; lesser toe deformity; claw toe; arthrodesis; resection arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Congenital Abnormalities; Hammer Toe Syndrome
• Other Study ID Numbers: 450/2014BO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No