Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
100 participants
OBSERVATIONAL
2013-04-30
2021-05-31
Brief Summary
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Detailed Description
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The secondary objectives are:
* to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition
* to determine pre- and post-operative HR QOL
* Incidence of radiolucencies at each follow up time point. Literature values from the same meta analysis will be used,
Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* patients willing to return for follow up evaluation.
Exclusion Criteria
* severe muscular, neurological or vascular deficiencies of the extremity involved
* bone destruction or poor bone to affect implant stability
* allergy to any of the components of the implant
18 Years
ALL
No
Sponsors
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Biomet Belgium BVBA
INDUSTRY
Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Frederik VERSTREKEN, PhD
Role: PRINCIPAL_INVESTIGATOR
SPM Deurne
Locations
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SPM Deurne
Deurne, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ORTHO.CR.E16
Identifier Type: -
Identifier Source: org_study_id