Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
NCT ID: NCT01121874
Last Updated: 2018-08-15
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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COMPLETED
NA
53 participants
INTERVENTIONAL
2010-04-12
2012-07-25
Brief Summary
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We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LRTI
These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique.
Ligament Reconstruction with Tendon Interposition (LRTI)
commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
Suture fixation system
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
Ligament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Suture fixation system + 2 week immobilization
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery.
Ligament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks.
Interventions
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Ligament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Ligament Reconstruction with Tendon Interposition (LRTI)
commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
Ligament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eaton Stage III or IV CMC arthritis
* Failure to respond to conservative treatment
Exclusion Criteria
* Upper extremity neurological dysfunction
* Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier
* Unwilling or unable to provide written informed consent
18 Years
ALL
No
Sponsors
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J&M Shuler
INDUSTRY
Responsible Party
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Michael Shuler
Hand and Upper Extremity Specialist
Principal Investigators
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Michael Shuler, MD
Role: PRINCIPAL_INVESTIGATOR
Athens Orthopedic Clinic, PA
Locations
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Athens Orthopedic Clinic
Athens, Georgia, United States
Countries
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Other Identifiers
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CMC-101
Identifier Type: -
Identifier Source: org_study_id
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