Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty
1 other identifier
interventional
37
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 25, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedMay 21, 2018
May 1, 2018
2.3 years
April 25, 2018
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Osseous consolidation
6months postoperatively
Study Arms (2)
Arthrodesis
EXPERIMENTALArthrodesis of the proximal interphalangeal joint by using a threaded K-wire
Resection arthroplasty
ACTIVE COMPARATORResection arthroplasty of the proximal interphalangeal joint using a normal K-wire
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior physician
Study Record Dates
First Submitted
April 25, 2018
First Posted
May 21, 2018
Study Start
January 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 21, 2018
Record last verified: 2018-05