Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy
Status: | Recruiting |
---|---|
Conditions: | Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | August 1, 2018 |
End Date: | June 30, 2022 |
Contact: | Chistopher M Frost, MD |
Email: | cfrost4@jhmi.edu |
Phone: | 410-550-0407 |
Surgical Management of Thumb Carpometacarpal Arthritis With Selective Joint Denervation Versus Trapeziectomy
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.
treatments for thumb carpo-metacarpal joint arthritis: trapeziectomy with ligament
reconstruction (LRTI) or denervation.
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.
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.
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
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Scott Lifchez, MD
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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