An interventional study of Ligament reconstruction with suture fixation system and Ligament Reconstruction with Tendon Interposition (LRTI) in Thumb Carpometacarpal Arthritis, sponsored by J&M Shuler. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-15.
Sponsored by J&M Shuler · Not applicable, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 53 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →J&M Shuler is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)
CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system.
Procedure: Ligament reconstruction with suture fixation system
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.
Procedure: Ligament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
Also known as: Arthrex Mini TightRope
commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
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.
Also known as: Arthrex Mini TightRope
Overall functionality
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).
Time frame: Baseline
Overall Functionality
Time frame: 6 wks
Overall Functionality
Time frame: 3 mos
Overall Functionality
Time frame: 6 mos
Overall Functionality
Time frame: 12 months
Overall Functionality
Time frame: 24 months
Analog pain scale
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.
Time frame: Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Strength measures
Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Range of motion
Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Operative time
Operative time in minutes
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
Scaphometacarpal distance
Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views
Time frame: Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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J&M Shuler