Clinical evaluation of Signature Personalized Patient Care Prospective, clinical, multicentre, randomised, double blind study
- Conditions
- gonarthrosisknee wear10005944
- Registration Number
- NL-OMON35099
- Lead Sponsor
- Orbis Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Painful and disabled knee joint resulting from osteoarthritis
One or more compartments are involved, as assessed by X-ray
High need to obtain pain relief and improve function
Above 18 years old (full skeletal maturity)
Body-mass-index (BMI) <35
Ablility and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
Consent form read, understood and signed by patient
Active infection in knee
General infection
Distant foci of infections which may spread to the implant site
Failure of previous joint replacement
Pregnancy
Previous major knee surgery, except for arthroscopic meniscectomy
Use of anticoagulants for any reason
Metal near knee joint (MRI-scan not possible)
Not able or willing to undergo MRI-scan
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints<br /><br>* American Knee Society Score at 2 year post-operative.<br /><br>* Radiographic evaluation at 6 weeks post-operative. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br>* KSS, WOMAC, VAS, Oxford Knee * 12, EQ-5D at each post-operative visit.<br /><br>* Operation time<br /><br>* Blood loss<br /><br>* Length of hospital stay<br /><br>* Complications/adverse events<br /><br>* Needed change of plans and reasons for changes<br /><br>* Survivorship at 10 years post-operative<br /><br>* Wear rate measured by radiographic evaluation at 1 Y, 2 Y, 5 Y and 10 Y<br /><br>post-operative.<br /><br>* All material Costs and EQ-5D during inpatient fase of study.</p><br>