Type \& Design:
Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled
Objectives:
1. Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS designs
2. Incidence of adverse events and identification of possible risk factors for unsatisfactory results
3. Mid-term survivorship of the implants
Who can participate
Age range
22 Years – 78 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and females
. Age 22-78 years
. Any race
. Ambulatory patients
. Patients who have a medical condition with over 5 years of life expectancy
. Patients with painful primary or secondary knee osteoarthritis
. Patients who have undamaged and functional collateral and posterior cruciate ligaments for the group requiring Physica CR or Patients who have undamaged and functional collateral ligaments for the group requiring Physica PS
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical change in Knee Society Score (KSS)
Timeframe: From preoperative (baseline) to 5 years after surgery
. Previous partial knee replacement or patellofemoral joint replacement and previous patellectomy
. Primary Total Knee Replacement (TKR) in the affected knee
. Varus deformity \>20° or Valgus deformity \>15°
. Patients with a fixed flexion contracture \>20°
. Previous intra-articular fractures of the affected knee
. Patients with previous methaphysal tibial or femoral osteotomy performed less than 5 years before the screening visit, in case of plate removal surgery it is done early than 1 year ago to screening.
. Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS\< 60 points
. Patients with symptomatic Osteoarthritis (OA) of the spine if the assessment of pain with Numeric Rating Scale is \>4