Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial

University of Oslo (UIO)

Status: Completed

Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Treatments: Procedure: Total joint replacement; Device: Elektra prosthesis; Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)

Study type: Interventional

Funder types: Other

Identifiers

NCT02556515

276-08457c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Trapeziektomi and ligament interposition

Active Comparator group

Description:

Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)

Treatment:

Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)

Total joint replacement

Experimental group

Description:

Elektra CMC1 uncemented prosthesis Elektra prosthesis

Treatment:

Procedure: Total joint replacement

Device: Elektra prosthesis