NCT02556515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2008

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

9.3 years

First QC Date

February 17, 2014

Last Update Submit

September 23, 2018

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Keywords

CMC1arthritisdegenerative arthritisthumbinterpositional arthroplastytotal joint replacement

Outcome Measures

Primary Outcomes (1)

  • quick-DASH

    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 Outcomes (1)

  • Nelson hospital score

    Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.

Other Outcomes (3)

  • Grip strength

    baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months

  • range of motion

    baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months

  • complications

    registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.

Study Arms (2)

Trapeziektomi and ligament interposition

ACTIVE COMPARATOR

Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)

Procedure: Interpositional arthroplasty (Burton-Pellegrini procedure)

Total joint replacement

EXPERIMENTAL

Elektra CMC1 uncemented prosthesis Elektra prosthesis

Procedure: Total joint replacementDevice: Elektra prosthesis

Interventions

Interpositional arthroplasty (Burton-Pellegrini procedure)PROCEDURE

Burton-Pellegrini procedure

Trapeziektomi and ligament interposition
Total joint replacementPROCEDURE

Total joint replacement

Also known as: Elektra prosthesis (Dijon, France)
Total joint replacement
Elektra prosthesisDEVICE

Elektra prosthesis

Total joint replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CMC 1 arthritis
  • Pain and dysfunction
  • Adult patients
  • General good health

You may not qualify if:

  • Pregnancy
  • STT arthritis (CT scan preoperatively for all patients)
  • Other injuries in thumb/hand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0021, Norway

Location

MeSH Terms

Conditions

ArthritisOsteoarthritis

Interventions

Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Rasmus Thorkildsen, MBBS(Bsc)

    Hand- and microsurgical unit, Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

February 17, 2014

First Posted

September 22, 2015

Study Start

November 24, 2008

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)