The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (KLS Martin Group) in vivo, using mRSA, over 10 years. Furthermore, the safety and usability of the tantalum markers and the marker inserter…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary study parameters are the survival of the CapFlex PIP implant system,
clinical scores and radiographic aspects.
Background summary
Patients with osteoarthritis (OA) of the proximal interphalangeal (PIP) joint
are commonly treated with joint arthroplasty. The CapFlex PIP implant system 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 stereogrammetric
analysis (mRSA), the migration pattern of the implant over time can be
calculated. To measure the migration, during surgery tantalum markers will be
inserted in the host bone using a marker inserter. The displacement of the
prosthesis with reference to the host bone will be measured using model-based
RSA. Both the tantalum markers and the inserter are already used for study
purposes. However, safety and usability are not registered before.
Study objective
The primary objective is to assess the fixation and migration patterns of the
CapFlex PIP implant system (KLS Martin Group) in vivo, using mRSA, over 10
years. Furthermore, the safety and usability of the tantalum markers and the
marker inserter will be determined. 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 burden and risks
Patients participating in the study will have the same risks when not
participating in the study. Also the markers and marker inserter are used
before without any problems in comparable studies. 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.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80120.058.22 |