Back to resultsMotec Versus Remotion Total Wrist Arthroplasty - A Prospective Study
Primary Purpose
Non-rheumatoid Wrist Arthritis
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Motec total wrist arthroplasty
Remotion total wrist arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Non-rheumatoid Wrist Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
- Age 18-70 years
- ASA class 1-3
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Motec total wrist arthroplasty
Remotion total wrist arthroplasty
Arm Description
Outcomes
Primary Outcome Measures
PRWHE (Patient rated Wrist and Hand Evaluation score)
PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function
Secondary Outcome Measures
Wrist movement
Overall degree of flexion, extension, radial and ulnar deviation
Grip Strength
Pain in affected wrist
Visual analogue scale
Quick-DASH
"Disabilities of the Arm, Shoulder and Hand" questionnaire
intraoperative complications
Postoperative complications
Implant loosening
Implant loosening seen on x-ray
Implant migration
Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening
Periprosthetic bone mineral density
BMD measured with DEXA (dual-energy x-ray absorptiometry)
Reoperations
Reoperations of any cause
Full Information
NCT ID
NCT01842724
First Posted
April 22, 2013
Last Updated
September 15, 2021
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01842724
Brief Title
Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study
Official Title
Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2034 (Anticipated)
Study Completion Date
November 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the difference in the results between Motec and Remotion wrist arthroplasty in the treatment of non-rheumatoid wrist arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-rheumatoid Wrist Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motec total wrist arthroplasty
Arm Type
Active Comparator
Arm Title
Remotion total wrist arthroplasty
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Motec total wrist arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Remotion total wrist arthroplasty
Primary Outcome Measure Information:
Title
PRWHE (Patient rated Wrist and Hand Evaluation score)
Description
PRWHE is a wrist specific patient assessed questionnaire, measuring pain, wrist specific function and general function
Time Frame
24 months postop
Secondary Outcome Measure Information:
Title
Wrist movement
Description
Overall degree of flexion, extension, radial and ulnar deviation
Time Frame
24 months postop
Title
Grip Strength
Time Frame
24 months postop
Title
Pain in affected wrist
Description
Visual analogue scale
Time Frame
24 months postop
Title
Quick-DASH
Description
"Disabilities of the Arm, Shoulder and Hand" questionnaire
Time Frame
24 months postop
Title
intraoperative complications
Time Frame
intraoperative
Title
Postoperative complications
Time Frame
24 months postop
Title
Implant loosening
Description
Implant loosening seen on x-ray
Time Frame
24 months postop
Title
Implant migration
Description
Implant migration seen on model-based roentgen stereophotogrammetric analysis (RSA), as a possible precursor of later implant loosening
Time Frame
24 months postop
Title
Periprosthetic bone mineral density
Description
BMD measured with DEXA (dual-energy x-ray absorptiometry)
Time Frame
24 months postop
Title
Reoperations
Description
Reoperations of any cause
Time Frame
24 months postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Patients with painful non-rheumatoid wrist arthritis (posttraumatic arthritis and late stage Kienboeck's disease)
Age 18-70 years
ASA class 1-3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trygve Holm Glad, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
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Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study
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