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

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.
 
ClinicalTrials.gov Identifier: NCT01554748
Recruitment Status : Recruiting
First Posted : March 15, 2012
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro

Tracking Information
First Submitted Date  ICMJE March 12, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date February 13, 2020
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)		 Implant survival [ Time Frame: 10 year survival ]
Revision with removal of implant
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)		 Implant survival [ Time Frame: 10 year survival ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Official Title  ICMJE Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Implantation of TMC total joint arthroplasty in a patient cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Procedure: Total joint arthroplasty
Study Arms  ICMJE Patient cohort
TMC total joint arthroplasty
Intervention: Procedure: Total joint arthroplasty
Publications * Mosegaard SB, Stilling M, Hansen TB. Risk factors for limited improvement after total trapeziometacarpal joint arthroplasty. Health Qual Life Outcomes. 2020 Mar 30;18(1):90. doi: 10.1186/s12955-020-01333-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2018)		 400
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)		 100
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

  • Patients with Eaton type 4 TMC osteoarthritis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554748
Other Study ID Numbers  ICMJE 2012-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Torben B. Hansen, Regional Hospital Holstebro
Study Sponsor  ICMJE Regional Hospital Holstebro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Torben B. Hansen, MD, PhD Orthopaedic Research Unit Regional Hospital Holstebro
PRS Account Regional Hospital Holstebro
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP