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Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

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ClinicalTrials.gov Identifier: NCT03530839
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Ulf Krister Hofmann, University Hospital Tuebingen

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017
Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Osseous consolidation [ Time Frame: 6months postoperatively ]
    Osseous consolidation of the procedure was evaluated using x-rays


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr. Ulf Krister Hofmann, Senior physician, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03530839    
Other Study ID Numbers: 450/2014BO1
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ulf Krister Hofmann, University Hospital Tuebingen:
lesser toe deformity
claw toe
PIP joint
arthrodesis
resection arthroplasty
Additional relevant MeSH terms:
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Hammer Toe Syndrome
Congenital Abnormalities
Foot Deformities
Musculoskeletal Diseases