Clinical trial NCT03558204: Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy
Official title: Surgical Management of Thumb Carpometacarpal Arthritis With Selective Joint Denervation Versus Trapeziectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thumb Osteoarthritis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See above

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Hand Function
timeFrame: Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6, months, 12 months, and 2 years.
measure: Change in grip and lateral pinch strength
timeFrame: Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years.
measure: Change in pain level
timeFrame: Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years.
measure: narcotic pain medication usage
timeFrame: Up to 3 months.
Secondary outcomes:
measure: Time to release to unrestricted activity
timeFrame: Up to 6 months.
measure: Operative duration
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Scott D Lifchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Yuan F, Aliu O, Chung KC, Mahmoudi E. Evidence-Based Practice in the Surgical Treatment of Thumb Carpometacarpal Joint Arthritis. J Hand Surg Am. 2017 Feb;42(2):104-112.e1. doi: 10.1016/j.jhsa.2016.11.029.
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