- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740999
Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint
Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint
The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.
The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zürich, Switzerland, 8008
- Schulthess Klinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary osteoarthritis in the distal interphalangeal joint
- require surgical treatment
- patient aged 18 years and over
- signed written informed consent
Exclusion Criteria:
- posttraumatic osteoarthritis
- rheumatoid disease
- pregnant woman
- any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- legal incompetence
- no knowledge of German
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: silicone arthroplasty
|
silicone arthroplasty
|
ACTIVE_COMPARATOR: arthrodesis
|
arthrodesis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Michigan Hand Questionnaire (MHQ)
Time Frame: 12 months postoperative
|
Comparison of silicone arthroplasty and arthrodesis in respect to MHQ
|
12 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Michigan Hand Questionnaire Score
Time Frame: preoperative, 3mo/6mo/36mo postoperative
|
preoperative, 3mo/6mo/36mo postoperative
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of objective clinical parameters
Time Frame: preoperative, 3mo/6mo/12mo/36mo postoperative
|
measurements of grip strength and range of motion
|
preoperative, 3mo/6mo/12mo/36mo postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Other Study ID Numbers
- DIP_01
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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