Skip to main content
Clinical Trials/NCT02556515
NCT02556515
Completed
Not Applicable

Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb

Oslo University Hospital1 site in 1 country40 target enrollmentNovember 24, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Sponsor
Oslo University Hospital
Enrollment
40
Locations
1
Primary Endpoint
quick-DASH
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Interpositional arthroplasty is by many considered to be the current gold standard for the treatment of thumb carpometacarpal arthritis. The results are generally good, but the rehabilitation time can be long and failures are difficult to treat. Total joint replacements now exist with modern uncemented designs that can be an alternative treatment. Short term studies show that thumb function often is better and rehabilitation time shorter, however there is uncertainty with regards to the longevity of the implants. Currently no prospective randomized trials have compared these two treatment options. Our hypothesis is that the total joint replacement will give the same results or better when compared to the interpositional arthroplasty.

Detailed Description

Eligible: patients \>18 years with pain and dysfunction from the first cmc joint. Clinical and radiological arthritis. Exclusion: degenerative changes in the STT joint (all patients are assessed by CT), other injuries in the hand/thumb, pregnancy Outcome measures: quick-Dash, Nelson hospital score, range of motion, grip strength Complications are registered. The patients are observed for two years and the investigators aim to include a total of 40 patients.

Registry
clinicaltrials.gov
Start Date
November 24, 2008
End Date
March 16, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Rasmus Thorkildsen

Senior Consultant

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • CMC 1 arthritis
  • Pain and dysfunction
  • Adult patients
  • General good health

Exclusion Criteria

  • Pregnancy
  • STT arthritis (CT scan preoperatively for all patients)
  • Other injuries in thumb/hand

Outcomes

Primary Outcomes

quick-DASH

Time Frame: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.

two-page questionnaire with VAS-scale for pain and function.

Secondary Outcomes

  • Nelson hospital score(Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.)

Study Sites (1)

Loading locations...

Similar Trials