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Completed

NCT Number: NCT03530839

Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

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.

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Key information

Conditions

Claw Toe Ankylosis Foot Deformities Hammer Toe Syndrome Joint Diseases Lesser Toe Deformity Musculoskeletal Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arthrodesis

Procedure

see study group description

Resection arthroplasty

Procedure

see study group description

Primary outcomes

  1. Pain

    Time frame: 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))

  2. Function

    Time frame: 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 outcomes

  1. Osseous consolidation

    Time frame: 6months postoperatively

    Osseous consolidation of the procedure was evaluated using x-rays

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 21, 2018
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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