Persona Partial Knee - a RSA study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is migration of both the tibial and femoral components<br /><br>of the prosthesis using mRSA, expressed as translations (mm) and rotations<br /><br>(degrees). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to analyze short- and midterm clinical results by<br /><br>means of numeric rating scale (NRS) for pain, range of motion (ROM), Knee<br /><br>injury and Osteoarthritis Outcome Score (KOOS-PS), Oxford Knee Score (OKS),<br /><br>Knee Society Score (KSS) EuroQoL-5D (EQ-5D), radiographic results and<br /><br>satisfaction.</p><br>