Clinical trial NCT06467669: Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation
Official title: Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CMC Arthritis
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: The thumb (or first) carpometacarpal (CMC) joint is commonly affected by osteoarthritis. Literature has reported a prevalence of 15% in women and 7% in men. First CMC joint osteoarthritis can present with decreased grip strength, pain, instability and inability to engage in routine daily activities. Definitive management is with surgery, however these are associated with known risks and increased weight times for the patient. First CMC joint denervation surgery is supported in the literature as a safe and effective approach to treat pain, strength, and thumb opposition which still allows for definitive surgery to be performed later if the arthritis progressed or if the pain returned later after the surgery.

Objectives: (1) evaluate the effectiveness of the neurectomy in patients with with CMC arthritis with respect to pain relief, functional parameters, and Quick disabilities of the arm, shoulder and hand (QuickDASH) scores; (2) to determine whether pain relief with selective nerve blocks are predictive of the outcome of the combined neurectomy; and (3) to determine whether improvement in grip strength following selective blocks is predictive of final grip strength and outcome following neurectomy.

Methods: Patients referred to the plastic surgery clinic for assessment of symptomatic first CMC joint osteoarthritis will be provided options for standard treatment or denervation procedure. Patients who agree to denervation will undergo local anesthetic block at their initial consult. At their initial consultation as well as at the 2-week, 3-month, 6-month, 12-month and 24-month post-surgical follow-up, patients will complete a QuickDASH, Kapandji score, pain scores, 2-point discrimination and grip/key/3-point strength measurements. The total patient population included in this study will be 60 patients.


Eligibility criteria: Inclusion Criteria:

* Radiographic Eaton stage 2 or 3 1st carpometacarpal joint arthritis
* Failed medical management, requesting surgical intervention

Exclusion Criteria:

* Pediatric population
* Eaton stage 1 or 4
* Medically unfit for procedure

Primary outcomes:
measure: Pain outcomes from neurectomy
timeFrame: 2 years
Secondary outcomes:
measure: Selective nerve block pain predictions
timeFrame: 2 years
measure: Selective nerve block grip strength predictions
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Aaron Knox, MD
role: PRINCIPAL_INVESTIGATOR
References:
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