Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-03 @ 10:31 AM
Study NCT ID:
NCT06467669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Predictive Outcomes for Selective Thumb Carpometacarpal Joint Denervation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: