Thumb Carpometacarpal Arthritis
Conditions
Keywords
CMC arthritis, thumb carpometacarpal arthritis, basal joint arthritis, thumb CMC arthritis
Brief summary
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.
Interventions
PROCEDURELigament reconstruction with suture fixation system
CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
PROCEDURELigament 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.
Sponsors
J&M Shuler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall functionality | 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). |
| Overall Functionality | 6 wks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos | Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm). |
| Analog pain scale | 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. |
| Scaphometacarpal distance | 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 |
| Operative time | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos | Operative time in minutes |
| Strength measures | 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 |
Countries
United States
Outcome results
None listed