Last updated: October 27, 2023
Sponsor: Reinier Haga Orthopedisch Centrum
Overall Status: Active - Recruiting
Phase
N/A
Condition
Osteoarthritis
Treatment
CapFlex PIP implant
Clinical Study ID
NCT05484089
OC-2021-019
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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
Study Design
Total Participants: 36
Treatment Group(s): 1
Primary Treatment: CapFlex PIP implant
Phase:
Study Start date:
October 25, 2023
Estimated Completion Date:
October 31, 2035
Connect with a study center
Reinier Haga Orthopedisch Centrum
Zoetermeer, Zuid-Holland 2725 NA
NetherlandsActive - Recruiting
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