Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
NCT ID: NCT05753891
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-04-01
2025-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carpometacarpal (CMC) Suture Tape Ligament Reconstruction
Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group.
Suture Tape Reconstruction
This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
Carpometacarpal (CMC) Standard Ligament Reconstruction
Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition.
No interventions assigned to this group
Interventions
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Suture Tape Reconstruction
This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptomatic basilar thumb arthritis refractory to conservative management
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Charles S Day
Interim Chairman & Medical Director, Professor of Orthopaedic Surgery, Department of Orthopaedic Surgery & Service Line, Wayne State University School of Medicine, Henry Ford Health
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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16162
Identifier Type: -
Identifier Source: org_study_id
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