- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121874
Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
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Athens, Georgia, United States, 30606
- Athens Orthopedic Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients aged >18.
- Eaton Stage III or IV CMC arthritis
- Failure to respond to conservative treatment
Exclusion Criteria:
- Previous surgical interventions on that thumb
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
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commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
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EXPERIMENTAL: Suture fixation system
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
|
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Other Names:
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 Names:
|
EXPERIMENTAL: 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.
|
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall functionality
Time Frame: Baseline
|
Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity).
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Baseline
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Overall Functionality
Time Frame: 6 wks
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6 wks
|
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Overall Functionality
Time Frame: 3 mos
|
3 mos
|
|
Overall Functionality
Time Frame: 6 mos
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6 mos
|
|
Overall Functionality
Time Frame: 12 months
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12 months
|
|
Overall Functionality
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analog pain scale
Time Frame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Pain will be assessed using the visual analog pain scale, which asks the patient to rate their pain on a scale from 1 to 10.
|
Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Strength measures
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
|
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
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Range of motion
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
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Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
|
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Operative time
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Operative time in minutes
|
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Scaphometacarpal distance
Time Frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal.
Taken in stressed and relaxed views
|
Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMC-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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