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

This study is currently recruiting participants.
Verified August 2015 by Torben B. Hansen, Regional Hospital Holstebro
Sponsor:
ClinicalTrials.gov Identifier:
NCT01554748
First Posted: March 15, 2012
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro
  Purpose
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.

Condition Intervention Phase
Osteoarthritis Other: implant fixation with different techniques and designs Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

Further study details as provided by Torben B. Hansen, Regional Hospital Holstebro:

Primary Outcome Measures:
  • Implant survival [ Time Frame: 10 year survival ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
implant fixation
implant fixation with different techniques
Other: implant fixation with different techniques and designs
implant fixation cemented/uncemented

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

  • Patients with Eaton type 4 TMC osteoarthritis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554748


Locations
Denmark
Department of Orthopaedics, Regional Hospital Holstebro Recruiting
Holstebro, Denmark, DK-7500
Contact: Torben B. Hansen, MD, PhD       torbehns@rm.dk   
Principal Investigator: Torben B. Hansen, MD, PhD         
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Torben B. Hansen, MD, PhD Orthopaedic Research Unit Regional Hospital Holstebro
  More Information

Responsible Party: Torben B. Hansen, Professor, MD, PhD, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01554748     History of Changes
Other Study ID Numbers: 2012-01
First Submitted: March 12, 2012
First Posted: March 15, 2012
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Torben B. Hansen, Regional Hospital Holstebro:
total joint arthroplasty
thumb
trapeziometacarpal joint
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases


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