Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy

Thumb Osteoarthritis Clinical Trial

Official title:

Surgical Management of Thumb Carpometacarpal Arthritis With Selective Joint Denervation Versus Trapeziectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558204
• Other study ID #: IRB00154490
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: June 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Procedure:
• Denervation of the thumb CMC joint
Removal/disconnection of the nerve branches to the joint from their attachments to the joint
• trapeziectomy with ligament reconstruction (LRTI)
excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Aliu O, Davis MM, DeMonner S, Chung KC. The influence of evidence in the surgical treatment of thumb basilar joint arthritis. Plast Reconstr Surg. 2013 Apr;131(4):816-828. doi: 10.1097/PRS.0b013e3182818d08. — View Citation

Chung KC, Hamill JB, Walters MR, Hayward RA. The Michigan Hand Outcomes Questionnaire (MHQ): assessment of responsiveness to clinical change. Ann Plast Surg. 1999 Jun;42(6):619-22. doi: 10.1097/00000637-199906000-00006. — View Citation

Giesen T, Klein HJ, Franchi A, Medina JA, Elliot D. Thumb carpometacarpal joint denervation for primary osteoarthritis: A prospective study of 31 thumbs. Hand Surg Rehabil. 2017 Jun;36(3):192-197. doi: 10.1016/j.hansur.2017.01.007. Epub 2017 Apr 25. — View Citation

Haase SC, Chung KC. An evidence-based approach to treating thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2011 Feb;127(2):918-925. doi: 10.1097/PRS.0b013e3182046901. — View Citation

Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale — View Citation

Leamy DJ, Kocijan J, Domijan K, Duffin J, Roche RA, Commins S, Collins R, Ward TE. An exploration of EEG features during recovery following stroke - implications for BCI-mediated neurorehabilitation therapy. J Neuroeng Rehabil. 2014 Jan 28;11:9. doi: 10.1 — View Citation

Waljee JF, Chung KC. Outcomes research in rheumatoid arthritis. Hand Clin. 2011 Feb;27(1):115-26. doi: 10.1016/j.hcl.2010.10.005. — View Citation

Wolf JM, Delaronde S. Current trends in nonoperative and operative treatment of trapeziometacarpal osteoarthritis: a survey of US hand surgeons. J Hand Surg Am. 2012 Jan;37(1):77-82. doi: 10.1016/j.jhsa.2011.10.010. Epub 2011 Nov 25. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hand Function	brief Michigan Hand Questionnaire (MHQ). (score ranges from 0 to 100, lower score indicates better function)	Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6, months, 12 months, and 2 years.
Primary	Change in grip and lateral pinch strength	position 2 on dynamometer (grip) and pinch meter (both are measured in kg of force, higher value indicates more strength)	Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years.
Primary	Change in pain level	Likert scale (score ranges from 0-10, lower score indicates less pain)	Through study completion at 2 years. Measurements will be performed prior to surgery, at 3 months, 6 months, 12 months, and 2 years.
Primary	narcotic pain medication usage	number of oxycodone 5 mg tablets (or equivalent) used after surgery (lower value indicates fewer narcotic tablets used)	Up to 3 months.
Secondary	Time to release to unrestricted activity	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).	Up to 6 months.
Secondary	Operative duration	Tourniquet time and surgery start to surgery end time (both measured in minutes, lower values indicate the surgery took less time to complete)	Up to 1 day