Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy
- Conditions
- Thumb Osteoarthritis
- Interventions
- Procedure: trapeziectomy with ligament reconstruction (LRTI)Procedure: Denervation of the thumb CMC joint
- Registration Number
- NCT03558204
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
This is a prospective study tracking the outcomes of patients who undergo either of two treatments for thumb carpo-metacarpal joint arthritis: trapeziectomy with ligament reconstruction (LRTI) or denervation.
- Detailed Description
A total of 100 patients with carpo-metacarpal (CMC) arthritis will be enrolled in the study. The design of the study is a prospective non-blinded, non-randomized control study. Enrollment will occur at the time of initial clinic visit. All patients presenting with CMC arthritis and deemed appropriate for surgery will be considered for screened for inclusion. As a part of routine workup for CMC arthritis patients receive a hand xray. Specific attendings will perform their preferred technique for CMC arthritis: two perform denervation of the CMC joint, and two perform trapeziectomy with ligament reconstruction tendon-interposition (LRTI) only per their normal clinical practice.
Pre-operative and peri-operative care will be unchanged from standard patient care. Both procedures are outpatient procedures, usually performed under regional anesthesia and patients go home the same day. Patients are discharged with a standard thumb spica splint which is removed on their first clinic appointment which is generally post-operative day 7.
Patients enrolled in the study will have additional follow up at the 3, 6, 12 and 24 month time points. At the 3, 6, 12 and 24 month time points patients will be asked to come to clinic for evaluation with 1) a standard hand questionnaire the Michigan Hand Questionnaire, 2) lateral pinch strength, grip strength and range of motion testing, 3) Kapandji score, 4) visual analog pain scale. Each visit will take approximately 15 minutes. Patients who are unable to follow up in clinic will be given a phone questionnaire with the Michigan Hand Questionnaire, visual analog pain scale and opiate usage. There is no monetary compensation for participation in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- Adult men and women (>18 years of age) No prior traumatic thumb injuries (fractures, dislocation) No concurrent thumb procedures scheduled Eaton/Littler stage 2-4 osteoarthritis9 Minimal CMC joint subluxation on x-ray
- Traumatic thumb injury (fracture, dislocation) Prior thumb surgery proximal to the interphalangeal joint. Non-fluent English Speaking Planned concurrent procedures on the thumb eg ganglion removal, trigger thumb release
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description trapeziectomy with ligament reconstruction (LRTI) trapeziectomy with ligament reconstruction (LRTI) Patients will undergo excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon CMC denervation Denervation of the thumb CMC joint Patients will undergo denervation of the thumb CMC joint
- Primary Outcome Measures
Name Time Method Change in grip and lateral pinch strength Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years. position 2 on dynamometer (grip) and pinch meter (both are measured in kg of force, higher value indicates more strength)
Change in pain level Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years. Likert scale (score ranges from 0-10, lower score indicates less pain)
narcotic pain medication usage Up to 3 months. number of oxycodone 5 mg tablets (or equivalent) used after surgery (lower value indicates fewer narcotic tablets used)
Change in Hand Function Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6, months, 12 months, and 2 years. brief Michigan Hand Questionnaire (MHQ). (score ranges from 0 to 100, lower score indicates better function)
- Secondary Outcome Measures
Name Time Method Time to release to unrestricted activity Up to 6 months. Number of days between surgery day and when patient is released to unrestricted activity (lower value indicates fewer days between day of surgery and when the patient was released to unrestricted activity).
Operative duration Up to 1 day Tourniquet time and surgery start to surgery end time (both measured in minutes, lower values indicate the surgery took less time to complete)
Trial Locations
- Locations (1)
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States