CapFlex-PIP© Motion
Completed
- Conditions
- ReplacementFinger JointArthroplastyMotion
- Registration Number
- NCT02425319
- Lead Sponsor
- Schulthess Klinik
- Brief Summary
The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or
- Patient with one untreated healthy hand without joint osteoarthritis
- Patient aged 50 years and over
- Patient willing and able to give written informed consent to participate in the study
Exclusion Criteria
- Inflammatory disease (e.g. rheumatoid arthritis)
- Pregnant women
- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Legal incompetence
- Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lateral stability in coronal plane (to ulnar and radial side) during motion analysis 1-5 years postoperative Active PIP joint range of motion (flexion and extension lag) during motion analysis 1-5 years postoperative
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms underlying CapFlex-PIP© implant efficacy in finger joint arthroplasty for osteoarthritis?
How does CapFlex-PIP© implant compare to silicone implants in restoring PIP joint kinematics and stability in osteoarthritis patients?
Are there specific biomarkers that can predict optimal patient selection for CapFlex-PIP© versus silicone implant arthroplasty in hand osteoarthritis?
What are the known adverse events associated with CapFlex-PIP© implants compared to traditional silicone implants in PIP joint replacement?
What are the current trends in PIP joint arthroplasty materials and how does CapFlex-PIP© fit within the therapeutic landscape of hand osteoarthritis?
Trial Locations
- Locations (1)
Schulthess Klinik
🇨🇭Zürich, Switzerland
Schulthess Klinik🇨🇭Zürich, Switzerland