NCT02556515

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Interventions

Type	Name	Description
PROCEDURE	Interpositional arthroplasty (Burton-Pellegrini procedure)	Burton-Pellegrini procedure
PROCEDURE	Total joint replacement	Total joint replacement
DEVICE	Elektra prosthesis	Elektra prosthesis

Timeline

• Start date: 2008-11-24
• Primary completion: 2018-03-16
• Completion: 2018-03-16
• First posted: 2015-09-22
• Last updated: 2018-09-25

Locations

1 site across 1 country: Norway