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
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
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
NCT ID
NCT02556515
First Posted
February 17, 2014
Last Updated
September 23, 2018
Sponsor
Oslo University Hospital
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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