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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Regional Hospital Holstebro
Sponsor:
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01554748
First received: March 12, 2012
Last updated: March 19, 2012
Last verified: March 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Implant survival [ Time Frame: 10 year survival ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Torben B. Hansen, Associated Professor, MD, PhD, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01554748     History of Changes
Other Study ID Numbers: 2012-01
Study First Received: March 12, 2012
Last Updated: March 19, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
total joint arthroplasty
thumb
trapeziometacarpal joint
osteoarthritis

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

ClinicalTrials.gov processed this record on July 31, 2014