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

Not Applicable

Completed

• Conditions: Osteoarthrosis of the Carpometacarpal Joint of the Thumb
• Interventions: Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure); Procedure: Total joint replacement; Device: Elektra prosthesis

• Registration Number: NCT02556515
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2008-11-24
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-23
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total joint replacement	Elektra prosthesis	Elektra CMC1 uncemented prosthesis Elektra prosthesis
Trapeziektomi and ligament interposition	Interpositional arthroplasty (Burton-Pellegrini procedure)	Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)
Total joint replacement	Total joint replacement	Elektra CMC1 uncemented prosthesis Elektra prosthesis

Primary Outcome Measures

Name	Time	Method
quick-DASH	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 Outcome Measures

Name	Time	Method
Nelson hospital score	Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.	one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway