NCT03558204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

4.5 years

First QC Date

April 5, 2018

Last Update Submit

June 8, 2023

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (2)

  • Time to release to unrestricted activity

    Up to 6 months.

  • Operative duration

    Up to 1 day

Study Arms (2)

CMC denervation

Patients will undergo denervation of the thumb CMC joint

Procedure: Denervation of the thumb CMC joint

trapeziectomy with ligament reconstruction (LRTI)

Patients will undergo excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon

Procedure: trapeziectomy with ligament reconstruction (LRTI)

Interventions

Denervation of the thumb CMC jointPROCEDURE

Removal/disconnection of the nerve branches to the joint from their attachments to the joint

CMC denervation
trapeziectomy with ligament reconstruction (LRTI)PROCEDURE

excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon

trapeziectomy with ligament reconstruction (LRTI)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See above

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (9)

  • 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.

    PMID: 21285797RESULT

  • 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.

    PMID: 23542253RESULT

  • 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.

    PMID: 28465206RESULT

  • 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 (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PMID: 22588748RESULT

  • 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: 10.1186/1743-0003-11-9.

    PMID: 24468185RESULT

  • 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.

    PMID: 10382797RESULT

  • 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.

    PMID: 22119601RESULT

  • 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.

    PMID: 28160900RESULT

  • 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.

    PMID: 21176806RESULT

Study Officials

  • Scott D Lifchez, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

June 15, 2018

Study Start

August 1, 2018

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

June 9, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)