Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2015 by Regional Hospital Holstebro
Sponsor:
Regional Hospital Holstebro
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01554748
First received: March 12, 2012
Last updated: August 18, 2015
Last verified: August 2015
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | March 12, 2012 | |||
| Last Updated Date | August 18, 2015 | |||
| Start Date ICMJE | January 2008 | |||
| Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Implant survival [ Time Frame: 10 year survival ] [ Designated as safety issue: Yes ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT01554748 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | 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 | Phase 4 | |||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | |||
| Intervention ICMJE | Other: implant fixation with different techniques and designs
implant fixation cemented/uncemented |
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| Study Arm (s) | implant fixation
implant fixation with different techniques
Intervention: Other: implant fixation with different techniques and designs |
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| Publications * | Not Provided | |||
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* 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 | 100 | |||
| Estimated Completion Date | January 2019 | |||
| Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | |||
| Ages | 18 Years to 80 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | 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 | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | 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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| Information Provided By | Regional Hospital Holstebro | |||
| Verification Date | August 2015 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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