degenerative joint disease, Osteoarthritis Osteoarthritis
Conditions
Interventions
None listed
Sponsors
Reinier Haga Orthopedisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Furthermore, the stability of the markers will be determined and the complications due to the markers and/or marker inserter will be registered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are the survival of the CapFlex PIP implant system, clinical scores and radiographic aspects. | — |
Countries
Netherlands
Contacts
Public ContactN.M.C. Mathijssen
Reinier Haga Orthopedisch Centrum
Outcome results
None listed