Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint

April 25, 2018 updated by: Schulthess Klinik

The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.

The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

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
      • Zurich, 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 to 111 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a DIP arthroplasty at least one year ago Matched patients with a DIP arthrodesis

Description

Inclusion Criteria:

Arthroplasty group:

  • DIP silicone arthroplasty at least one year ago
  • Informed consent as documented by signature

Arthrodesis group:

  • Matched patients with an DIP arthrodesis
  • Informed consent as documented by signature

Exclusion Criteria:

Arthroplasty group:

  • Silicone arthroplasty at the thumb IP joint
  • Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
  • Legal incompetence
  • German language barrier to complete the questionnaires

Arthrodesis group:

  • Arthroplasty at another DIP joint
  • Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
  • Legal incompetence
  • German language barrier to complete the questionnaires

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DIP arthroplasty
Device: DIP arthroplasty or arthrodesis
Arthroplasty of the DIP Joint or arthrodesis of the DIP joint
DIP arthrodesis
Device: DIP arthroplasty or arthrodesis
Arthroplasty of the DIP Joint or arthrodesis of the DIP joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up
Time Frame: at least 1 year up to 7 years
Question to be answered on a 5 Point Likert scale
at least 1 year up to 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michigan Hand Questionnaire
Time Frame: at least 1 year up to 7 years
Questionnaire about Hand function scored 0-100
at least 1 year up to 7 years

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 (Actual)

March 8, 2017

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • DIP_Silicone_retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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