- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02204488
Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2-3
Total Joint Arthroplasty or Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 2 and 3: a Randomized Clinical Trial
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. A relatively new treatment modality, which has been further developed in recent years is the total joint arthroplasty. Randomized prospective trials and long-term results are lacking, but prospective cohorts show a faster recovery and good results after one year, without an increase in complication rate.
We hypothesize that a total joint arthroplasty gives a better objective and subjective result after one year than a trapeziectomy.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Overijssel
-
Zwolle, Overijssel, Netherlands
- Recruiting
- Isala Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women.
- 40 years of age or more.
- Symptomatic trapeziometacarpal osteoarthritis.
- Eaton & Glickel stage 2 and 3.
Exclusion Criteria:
- An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
- Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
- Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
- Symptomatic carpal tunnel syndrome in same hand.
- Symptomatic Quervain's tenosynovitis in same hand.
- Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
- Insufficient knowledge of Dutch language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Total Joint Arthroplasty
|
Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France
|
Active Comparator: Trapeziectomy
|
Trapeziectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Michigan Hand Outcomes Questionnaire (MHOQ)
Time Frame: 1 year after surgery
|
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
|
1 year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Michigan Hand Outcomes Questionnaire (MHOQ)
Time Frame: 5 years after surgery
|
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
|
5 years after surgery
|
Michigan Hand Outcomes Questionnaire (MHOQ)
Time Frame: 1 and 5 years after surgery
|
Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e.
pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?
|
1 and 5 years after surgery
|
Disabilities of Arm Shoulder and Hand (DASH)
Time Frame: 1 and 5 years after surgery
|
Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?
|
1 and 5 years after surgery
|
Grip strength
Time Frame: 1 and 5 years after surgery
|
Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
|
1 and 5 years after surgery
|
Thumb mobility
Time Frame: 1 and 5 years after surgery
|
Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
|
1 and 5 years after surgery
|
Complications
Time Frame: 1 and 5 years after surgery
|
Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
|
1 and 5 years after surgery
|
Return to work
Time Frame: 1 and 5 years after surgery
|
Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
|
1 and 5 years after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jeroen H. van Uchelen, MD, Isala
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL47755.075.14 (Registry Identifier: METC Isala)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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