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

September 23, 2018 updated by: Rasmus Thorkildsen, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0021
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trapeziektomi and ligament interposition
Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)
Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)
Burton-Pellegrini procedure
Experimental: Total joint replacement
Elektra CMC1 uncemented prosthesis Elektra prosthesis
Procedure: Total joint replacement
Total joint replacement
Other Names:
  • Elektra prosthesis (Dijon, France)
Device: Elektra prosthesis
Elektra prosthesis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nelson hospital score
Time Frame: 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
Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months
Grip strength, key grip, tip-pinch measured by Jamar dynameter at each follow up
baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months
range of motion
Time Frame: baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months
Range of motion measured clinically (Kapandji opposition) and by x-ray (abduction, adduction, extension and flexion) at follow-up
baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months
complications
Time Frame: registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.
complications to either treatment form will be registered and published
registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Rasmus Thorkildsen, MBBS(Bsc), Hand- and microsurgical unit, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2008

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 23, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276-08457c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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