Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

February 11, 2020 updated by: Torben B. Hansen, Regional Hospital Holstebro
The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.

Study Type

Interventional

Enrollment (Anticipated)

400

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

  • Denmark
      • Holstebro, Denmark, DK-7500
        • Recruiting
        • Department of Orthopaedics, Regional Hospital Holstebro
        • Contact:
        • Principal Investigator:
          • Torben B. Hansen, MD, PhD

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

  • Patients with Eaton type 4 TMC osteoarthritis

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient cohort
TMC total joint arthroplasty
Procedure: Total joint arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: 10 year survival
Revision with removal of implant
10 year survival

Collaborators and Investigators

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

Sponsor

Regional Hospital Holstebro

Investigators

  • Principal Investigator: Torben B. Hansen, MD, PhD, Orthopaedic Research Unit Regional Hospital Holstebro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (ESTIMATE)

March 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-01 (AP HM)

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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