Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

Claw Toe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530839
• Other study ID #: 450/2014BO1
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Claw Toe
• Congenital Abnormalities
• Lesser Toe Deformity

Intervention

Procedure:
• Arthrodesis
see study group description
• Resection arthroplasty
see study group description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Osseous consolidation	Osseous consolidation of the procedure was evaluated using x-rays	6months postoperatively