Migration of the CapFlex-PIP implant system for proximal interphalangeal joint arthroplasy: a 10 year follow up RSA study

Recruiting

• Conditions: degenerative joint disease; Osteoarthritis; 10023213

• Registration Number: NL-OMON53919
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- Indication for PIP joint arthroplasty as described in the manufacturer's
guideline, namely as a result of: Painfull osteoarthritis or 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the migration of the CapFlex PIP implant system<br /><br>of the distal as well as the proximal component (presented in x-, y- and<br /><br>z-direction). Furthermore, the stability of the markers will be determined and<br /><br>the complications due to the markers and/or marker inserter will be registered.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary study parameters are the survival of the CapFlex PIP implant system,<br /><br>clinical scores and radiographic aspects. </p><br>