Actively Recruiting
CapFlex PIP Implant RSA
Led by Reinier Haga Orthopedisch Centrum · Updated on 2023-10-31
36
Participants Needed
1
Research Sites
622 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. To reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. By using model-based roentgen stereogrammaetric analysis (mRSA), the migration pattern of the implant over time can be calculated. Objective: The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (produced and developed by several companies of KLS Martin Group) in vivo, using mRSA, over 10 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the CapFlex PIP implant system. Study design: A prospective cohort study with 10 years follow-up, in which 36 patients will be enrolled. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years 5 years and 10 years. Study population: Patients 18 years or older who require a proximal interphalangeal joint arthroplasty as a result of osteoarthritis of a proximal interphalangeal joint. Main study parameters/endpoints: The main study parameters are the migration of the CapFlex PIP implant system of the distal as well as the proximal component (presented in x-, y- and z-direction). Secondary study parameters are the survival of the CapFlex PIP implant system, clinical scores and radiographic aspects. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the study will have the same risks when not participating in the study. Patients are asked to spend time to fill in the questionnaires and to have 3 extra visits to the hospital, next to the standard visits. Patients will have more follow up visits and will be followed using RSA analysis, which has as advantage that possible complications might be noticed earlier compared to normal follow up.
CONDITIONS
Official Title
CapFlex PIP Implant RSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for PIP joint arthroplasty as result of painful osteoarthritis or unstable comminuted 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 for stable implant fixation
- Known or suspected allergy to implant materials
- Previous revision surgery on the PIP joint
- Significant collateral instability
- Pregnancy or breastfeeding
AI-Screening
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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
CONTACT
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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