Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
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ClinicalTrials.gov Identifier: NCT01554748 |
Recruitment Status :
Recruiting
First Posted : March 15, 2012
Last Update Posted : February 13, 2020
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Sponsor:
Regional Hospital Holstebro
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro
Tracking Information | ||||
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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 |
Implant survival [ Time Frame: 10 year survival ] Revision with removal of implant
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Original Primary Outcome Measures ICMJE |
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 |
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Condition ICMJE | Osteoarthritis | |||
Intervention ICMJE | Procedure: Total joint arthroplasty | |||
Study Arms ICMJE | Patient cohort
TMC total joint arthroplasty
Intervention: Procedure: Total joint arthroplasty
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Recruiting | |||
Estimated Enrollment ICMJE |
400 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |