Physica System Total Knee Replacement Registry Study (NCT03048201) | Clinical Trial Compass
RecruitingNot Applicable
Physica System Total Knee Replacement Registry Study
United States800 participantsStarted 2017-03-24
Plain-language summary
The primary objective of this study is to obtain long-term implant survivorship (out to 10 years) and to assess clinical, patient-reported outcome measures, and radiographic data for the commercially available Physica system. For ancillary arm, from baseline to 5-year follow-up.
Who can participate
Age range
22 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
. Males and females of any race requiring a total knee replacement and suitable for the use of one of the configurations of the Physica system
. Age\> 22 (skeletally mature)
. Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):
. Suitable candidates for TKR who have undamaged and functional collateral ligaments
. Suitable candidates for TKR with Physica KR, CR, who have an undamaged and functional posterior cruciate ligament; or Physica LMC with or without a functioning posterior cruciate ligament or Physica PS with an absent or not-functioning posterior cruciate ligament and/or severe antero-posterior instability of the knee joint
. Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits
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.
. Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery
Exclusion criteria
. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function
. Patients with active or any suspected infection (on the affected knee or systemic)
. Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
. Patients with significant bone loss on femoral or tibial joint side
. Current treatment for malignant and/or life-threatening non-malignant disorders
. Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis