Clinical trial NCT02556515: Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial
Official title: Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Keywords: CMC1
arthritis
degenerative arthritis
thumb
interpositional arthroplasty
total joint replacement
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: quick-DASH
timeFrame: Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Secondary outcomes:
measure: Nelson hospital score
timeFrame: Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Other outcomes:
measure: Grip strength
timeFrame: baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months
measure: range of motion
timeFrame: baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months
measure: complications
timeFrame: registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Hand- and microsurgical unit, Oslo University Hospital
name: Rasmus Thorkildsen, MBBS(Bsc)
role: PRINCIPAL_INVESTIGATOR
References: