Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

NCT ID: NCT03530839

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Claw Toe Lesser Toe Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Arthrodesis

Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire

Group Type EXPERIMENTAL

Arthrodesis

Intervention Type PROCEDURE

see study group description

Resection arthroplasty

Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire

Group Type ACTIVE_COMPARATOR

Resection arthroplasty

Intervention Type PROCEDURE

see study group description

Interventions

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Arthrodesis

see study group description

Intervention Type PROCEDURE

Resection arthroplasty

see study group description

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ulf Krister Hofmann

Senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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450/2014BO1

Identifier Type: -

Identifier Source: org_study_id

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