Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

April 15, 2016 updated by: Sebastian Kluge, Schulthess Klinik

Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint

The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.

The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Schulthess Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary osteoarthritis in the distal interphalangeal joint
  • require surgical treatment
  • patient aged 18 years and over
  • signed written informed consent

Exclusion Criteria:

  • posttraumatic osteoarthritis
  • rheumatoid disease
  • pregnant woman
  • any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
  • legal incompetence
  • no knowledge of German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: silicone arthroplasty
Procedure: silicone arthroplasty
silicone arthroplasty
ACTIVE_COMPARATOR: arthrodesis
Procedure: arthrodesis
arthrodesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michigan Hand Questionnaire (MHQ)
Time Frame: 12 months postoperative
Comparison of silicone arthroplasty and arthrodesis in respect to MHQ
12 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of Michigan Hand Questionnaire Score
Time Frame: preoperative, 3mo/6mo/36mo postoperative
preoperative, 3mo/6mo/36mo postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of objective clinical parameters
Time Frame: preoperative, 3mo/6mo/12mo/36mo postoperative
measurements of grip strength and range of motion
preoperative, 3mo/6mo/12mo/36mo postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (ESTIMATE)

December 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DIP_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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