The primary objective of this study is to evaluate the fixation and migration patterns of the Persona Partial Knee (Zimmer Biomet, Warsaw, IN) in vivo, using model-based radiostereophotogrammetric (mRSA) analysis. The secondary objective is to…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is migration of both the tibial and femoral components
of the prosthesis using mRSA, expressed as translations (mm) and rotations
(degrees).
Secondary outcome
The secondary objective is to analyze short- and midterm clinical results by
means of numeric rating scale (NRS) for pain, range of motion (ROM), Knee
injury and Osteoarthritis Outcome Score (KOOS-PS), Oxford Knee Score (OKS),
Knee Society Score (KSS) EuroQoL-5D (EQ-5D), radiographic results and
satisfaction.
Background summary
In the Netherlands, 2.053 UKAs were performed in 2014, representing 9% of all
knee arthroplasties. The Persona Partial Knee (PKK) is a new unicondylar knee
replacement system, with a CE mark. It is of importance to evaluate new
prosthesis to know whether the prosthesis is stable. Historically, this was
analysed in survival studies, in which loosening was the primairy endpoint.
However, these studies lasted long and before the result of the study were
known, the prosthesis could be used frequently.
A newer method is Radiosteriometric analysis (RSA) in which the 2-year results
seem to be predictive for future loosening of the prosthesis.
RSA is a highly accurate, 3-dimensional method in which migration of the
prosthesis in the bone can be measured. It is frequently used in knee
prosthesis since the introduction. By using RSA we are able to analyse the
stability of the prosthesis. That way, we are able to recognize inferior
prostheses.
We would like to evaluate the fixation and migration patterns of the Persona
Partial Knee (Zimmer Biomet, Warsaw, IN) using RSA. We hypothesize that the
prosthesis is stable and has minimal translation, micromotion and rotation.
Study objective
The primary objective of this study is to evaluate the fixation and migration
patterns of the Persona Partial Knee (Zimmer Biomet, Warsaw, IN) in vivo, using
model-based radiostereophotogrammetric (mRSA) analysis.
The secondary objective is to analyze short- and midterm clinical results by
means of numeric rating scale (NRS) for pain, range of motion (ROM), Knee
injury and Osteoarthritis Outcome Score (KOOS-PS), Oxford Knee Score (OKS),
Knee Society Score (KSS) EuroQoL-5D (EQ-5D), radiographic results and
satisfaction.
Study design
We will perform a prospective cohort study at the Reinier de Graaf hospital,
Delft, the Netherlands. Patients will be recruited from the clinic of the
orthopedic department and evaluated preoperatively, at six weeks, six months,
one year, two years and five years. The study is expected to start on
01-02-2017 and end on 01-08-2024.
Intervention
Implantation of the Persona Partial Knee prosthesis, manufactured by Zimmer
Biomet (Warsaw, IN, USA).
Study burden and risks
Subjects participating in this study have the same risks and benefits when not
participating in this study, since the Persona Partial Knee is CE approved and
commercially available. 2 additional follow-up moments compared to regulair
care are scheduled (on 2 and 5 years after surgery). Furthermore, additional
assessments are RSA radiographs and implantation of tantalum marker beads.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
Specific indications for Persona Partial Knee:* Noninflammatory degenerative
joint disease (NIDJD), e.g. osteoarthritis, avascular necrosis
* Traumatic arthritis
* Previous tibial condyle or plateau fractures with loss of anatomy or function
* Varus deformities
* Revision of previous knee surgeries (Although this is an indication for the
PPK, patients with previous UKP in the same compartment will not be included in
this study. See *2.3 Exclusion criteria*)Subjects must additionally meet the
following criteria to participate in this study:
* Age >18 years
* Patient is willing to participate
* Patient is able to speak and write Dutch
* Patient qualifies for UKP based on physical exam and medical history
* Patient is able and willing to provide written informed consent
Exclusion criteria
Subjects will be excluded when they meet one or more of the following
contra-indications for the Persona Partial Knee:* Infection, sepsis, and
osteomyelitis
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Insufficiency of the collateral, anterior or posterior cruciate ligaments
which would preclude stability of the device
* Full thickness damage to the weight bearing area of the contralateral
compartment
* Uncooperative patient or patient with neurologic disorders who are incapable
of following directions
* Insufficient bone stock to provide adequate support and/or fixation to the
prosthesis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
* Charcot*s disease
* Fixed varus deformity (not passively correctable) or greater than 15 degrees
* Fixed flexion deformity (not passively correctable) of greater than 15
degrees. Additionally, subjects will be excluded when they meet the following
exlusion criteria:* Patient has a known or suspected sensitivity or allergy to
one or more of the implant materials
* Revision UKP surgery of the same compartment
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60028.098.16 |
| OMON | NL-OMON20822 |