Back to resultsLesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
Primary Purpose
Claw Toe, Lesser Toe Deformity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arthrodesis
Resection arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Claw Toe focused on measuring lesser toe deformity, claw toe, PIP joint, arthrodesis, resection arthroplasty
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arthrodesis
Resection arthroplasty
Arm Description
Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire
Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire
Outcomes
Primary Outcome Measures
Pain
Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
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))
Secondary Outcome Measures
Osseous consolidation
Osseous consolidation of the procedure was evaluated using x-rays
Full Information
NCT ID
NCT03530839
First Posted
April 25, 2018
Last Updated
May 8, 2018
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03530839
Brief Title
Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
Official Title
Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claw Toe, Lesser Toe Deformity
Keywords
lesser toe deformity, claw toe, PIP joint, arthrodesis, resection arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arthrodesis
Arm Type
Experimental
Arm Description
Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire
Arm Title
Resection arthroplasty
Arm Type
Active Comparator
Arm Description
Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire
Intervention Type
Procedure
Intervention Name(s)
Arthrodesis
Intervention Description
see study group description
Intervention Type
Procedure
Intervention Name(s)
Resection arthroplasty
Intervention Description
see study group description
Primary Outcome Measure Information:
Title
Pain
Description
Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
Time Frame
Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Title
Function
Description
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))
Time Frame
Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Secondary Outcome Measure Information:
Title
Osseous consolidation
Description
Osseous consolidation of the procedure was evaluated using x-rays
Time Frame
6months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
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