|- candidate number||26840|
|- NTR Number||NTR6283|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mrt-2017|
|- Secondary IDs||16-131 METC Zuidwest Holland|
|- Public Title||The Persona Partial Knee - an RSA study|
|- Scientific Title||The Persona Partial Knee - an RSA studie|
|- ACRONYM||PPK RSA|
|- hypothesis||The Persona Partial Knee (PPK) will have acceptable migration patterns at the two years follow-up mark|
|- Healt Condition(s) or Problem(s) studied||Knee osteoarhritis, Prothesis, implant technical complications, Arthroplasty , Radio Stereometric Analysis, Unicondylar|
|- Inclusion criteria||Indications for PPK prosthesis specifically:|
Noninflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, avascular necrosis
Previous tibial condyle or plateau fractures with loss of anatomy or function
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 Exclusion criteria)
Additional inclusion criteria for 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||Contra-indications for PPK prosthesis specifically:|
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
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
Fixed varus deformity (not passively correctable) or greater than 15 degrees
Fixed flexion deformity (not passively correctable) of greater than 15 degrees.
Additional exlusion criteria for this study:
Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
Revision UKP surgery of the same compartment
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2017|
|- planned closingdate||1-aug-2024|
|- Target number of participants||25|
|- Interventions||Placement of the Persona Partial Knee (PPK) unicondylar prosthesis, with insertion of tantalum beads for radiostereophotogrammetric analysis(RSA)|
|- Primary outcome||Fixation and migration patterns of the PPK prosthesis in vivo, using model-based RSA.|
|- Secondary outcome||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)
|- Timepoints|| Pre-operative|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| N.M.C. Mathijssen|
|- CONTACT for SCIENTIFIC QUERIES|| N.M.C. Mathijssen|
|- Sponsor/Initiator ||Department of Orthopaedics, Reinier de Graaf Groep|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Aseptic loosening is a common problem in joint arthroplasty and one of the most common indications for revision arthroplasty in total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). If unsatisfactory implant stability can be detected early or even predicted, fewer patients will be exposed to suboptimal prostheses. In the Netherlands, 2.053 UKAs were performed in 2014, representing 9% of all knee arthroplasties.
To our knowledge, no studies have used mRSA to investigate early migration of the Persona Partial Knee (PPK) (Zimmer Biomet, Warsaw, IN) in particular. The PPK is a unicondylar knee replacement system with a cobalt chromium alloy femoral component, titanium alloy tibial trays and plates and vitamin-E stabilized highly crosslinked polyethylene articular surface components. If mRSA data show that migration is within normal limits, the PKK can be implanted with more confidence in long term results. Conversely, if there is continuous or excessive migration the implant may be at risk for higher rates of future loosening.
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), EuroQoL-5D (EQ-5D) and radiographs.
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 population will consist of 25 subjects aged 18 or older, who are eligible for the Persona Partial Knee system and willing and able to participate
Intervention (if applicable): The Persona Partial Knee will be implanted according to the surgery protocol for this implant.
Main study parameters/endpoints:
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).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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. Patients have to visit the hospital on 2 additional occasions (2 and 5 years after surgery). The only additional assessments are RSA radiographs and implantation of tantalum marker beads.
|- Main changes (audit trail)|
|- RECORD||7-mrt-2017 - 26-mei-2017|