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

NCT ID: NCT02556515

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-24

Study Completion Date

2018-03-16

Brief Summary

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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

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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

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Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Trapeziektomi and ligament interposition

Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)

Group Type ACTIVE_COMPARATOR

Interpositional arthroplasty (Burton-Pellegrini procedure)

Intervention Type PROCEDURE

Burton-Pellegrini procedure

Total joint replacement

Elektra CMC1 uncemented prosthesis Elektra prosthesis

Group Type EXPERIMENTAL

Total joint replacement

Intervention Type PROCEDURE

Total joint replacement

Elektra prosthesis

Intervention Type DEVICE

Elektra prosthesis

Interventions

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Interpositional arthroplasty (Burton-Pellegrini procedure)

Burton-Pellegrini procedure

Intervention Type PROCEDURE

Total joint replacement

Total joint replacement

Intervention Type PROCEDURE

Elektra prosthesis

Elektra prosthesis

Intervention Type DEVICE

Other Intervention Names

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Elektra prosthesis (Dijon, France)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rasmus Thorkildsen

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasmus Thorkildsen, MBBS(Bsc)

Role: PRINCIPAL_INVESTIGATOR

Hand- and microsurgical unit, Oslo University Hospital

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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276-08457c

Identifier Type: -

Identifier Source: org_study_id

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