CapFlex PIP Implant RSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CapFlex PIP implant.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Hand. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study
Overview
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.
Interventions
- Device CapFlex PIP implant
Patients receive the CapFlex PIP implant based on regular care. During surgery tantalum markers are placed in the bone surrounding the implant.
Primary outcome measures
- The change in Translation in mm [Time frame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
Secondary outcome measures (7)
- Rotation in degrees [Time frame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
- Survival [Time frame: postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
- Radiographic aspects [Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
- Michigan Hand Outcomes Questionnaire (MHOQ) [Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
- Patient Rated Wrist / Hand Evaluation (PRWHE) [Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
- EuroQol-5D (EQ-5D-5L) [Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
- Numeric Rating Scale (NRS) [Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.]
Eligibility criteria
Inclusion criteria
- Indication for PIP joint arthroplasty as described in the manufacturer's guideline, namely as a result of:
- Painful osteoarthritis
- Instable communitive intra-articular PIP fractures
- Age > 18 years
- Patient is able to speak and write Dutch
- Patient is willing to participate
- Patient is able and willing to provide written informed consent
Exclusion criteria
- Inflammatory arthritis with significant bone loss
- Insufficient bone quality to provide adequate stability
- Known or suspected sensitivity or allergy to one or more of the implant materials
- Revision surgery
- Significant collateral instability
- Pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Reinier Haga Orthopedisch Centrum — Zoetermeer
Identifiers
NCT: NCT05484089 · OC-2021-019