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 range22 Years
SexALL
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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
✓. 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