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

Primary Purpose

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Interpositional arthroplasty (Burton-Pellegrini procedure)
Total joint replacement
Elektra prosthesis
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthrosis of the Carpometacarpal Joint of the Thumb focused on measuring CMC1, arthritis, degenerative arthritis, thumb, interpositional arthroplasty, total joint replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital, Rikshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Trapeziektomi and ligament interposition

Total joint replacement

Arm Description

Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)

Elektra CMC1 uncemented prosthesis Elektra prosthesis

Outcomes

Primary Outcome Measures

quick-DASH
two-page questionnaire with VAS-scale for pain and function.

Secondary Outcome Measures

Nelson hospital score
one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528

Full Information

First Posted
February 17, 2014
Last Updated
September 23, 2018
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02556515
Brief Title
Joint Replacement or Interpositional Arthroplasty for CMC1 Arthritis, a Prospective Trial
Official Title
Total Joint Replacement or Interpositional Arthroplasty for the Treatment of Arthritis in the Carpometacarpal Joint of the Thumb
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 24, 2008 (Actual)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Keywords
CMC1, arthritis, degenerative arthritis, thumb, interpositional arthroplasty, total joint replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trapeziektomi and ligament interposition
Arm Type
Active Comparator
Arm Description
Interpositional arthroplasty Interpositional arthroplasty (Burton-Pellegrini procedure)
Arm Title
Total joint replacement
Arm Type
Experimental
Arm Description
Elektra CMC1 uncemented prosthesis Elektra prosthesis
Intervention Type
Procedure
Intervention Name(s)
Interpositional arthroplasty (Burton-Pellegrini procedure)
Intervention Description
Burton-Pellegrini procedure
Intervention Type
Procedure
Intervention Name(s)
Total joint replacement
Other Intervention Name(s)
Elektra prosthesis (Dijon, France)
Intervention Description
Total joint replacement
Intervention Type
Device
Intervention Name(s)
Elektra prosthesis
Intervention Description
Elektra prosthesis
Primary Outcome Measure Information:
Title
quick-DASH
Description
two-page questionnaire with VAS-scale for pain and function.
Time Frame
Baseline (preoperatively), and change from baseline postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Secondary Outcome Measure Information:
Title
Nelson hospital score
Description
one page thumb-specific questionnaire first published In Journal of Hand Surgery (Eur) 2007, 32E: 5: 524-528
Time Frame
Baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months.
Other Pre-specified Outcome Measures:
Title
Grip strength
Description
Grip strength, key grip, tip-pinch measured by Jamar dynameter at each follow up
Time Frame
baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24months
Title
range of motion
Description
Range of motion measured clinically (Kapandji opposition) and by x-ray (abduction, adduction, extension and flexion) at follow-up
Time Frame
baseline (preoperatively) and change from base line postoperatively at 6 weeks, 3, 6, 12 and 24 months
Title
complications
Description
complications to either treatment form will be registered and published
Time Frame
registered at 2 and 6 weeks. Thereafter at 3,6, 12 and 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus Thorkildsen, MBBS(Bsc)
Organizational Affiliation
Hand- and microsurgical unit, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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