Actively Recruiting
Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study
Led by Reinier Haga Orthopedisch Centrum · Updated on 2023-10-31
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with osteoarthritis affecting the proximal interphalangeal (PIP) joint to understand the long-term behavior of the CapFlex PIP implant system. This implant is a modular surface replacement used in joint arthroplasty, which has shown good short-term results with few complications. The study aims to assess how well the implant attaches and whether it moves over time by using a special imaging technique called model-based roentgen stereogrammetric analysis (mRSA) across 10 years. Patients receive the CapFlex PIP implant as part of their regular treatment, during which small markers are placed in the bone around the implant. The study follows 36 patients, checking them before surgery and then at 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years after surgery. This allows researchers to track the implant's movement in three directions, its survival, clinical function, and X-ray features over time. Participants will attend multiple visits for evaluations including imaging with RSA, clinical questionnaires about hand function and quality of life, and pain assessments. These extra visits occur alongside their usual care to help detect any problems with the implant early. The study measures changes in implant position, rotation, survival, and patient-reported outcomes, with follow-up lasting 10 years to provide detailed long-term information.
CONDITIONS
Brief Title
CapFlex PIP Implant RSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for proximal interphalangeal joint arthroplasty due to painful osteoarthritis or unstable communitive intra-articular PIP fractures
- Age over 18 years
- Ability to speak and write Dutch
- Willingness to participate
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Inflammatory arthritis with significant bone loss
- Insufficient bone quality to provide adequate stability
- Known or suspected allergy to implant materials
- Previous revision surgery of the joint
- Significant collateral ligament instability
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge from hospital
Participants receive the CapFlex PIP implant as part of routine care. During surgery, tantalum markers are placed in the bone surrounding the implant.
1 surgery visit and immediate post-operative care
Duration - 10 years
Participants undergo assessments to monitor implant migration, radiographic aspects, and hand function over 10 years.
7 visits at postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years
Trial Site Locations
Total: 1 location
1
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, Netherlands, 2725 NA
Actively Recruiting
Research Team
N
N.M.C. Mathijssen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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