RecruitingOsteoarthritis, KneeTraumatic ArthritisAvascular Necrosis
Physica System Total Knee Replacement Registry Study
Eligible age
22+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Limacorporate S.p.a
You may qualify if…
- ✓ 1. 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
- ✓ 2. Age\> 22 (skeletally mature)
- ✓ 3. Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):
- ✓ including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity
- ✓ 4. Suitable candidates for TKR who have undamaged and functional collateral ligaments
- ✓ 5. 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
- ✓ 6. 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
- ✓ 7. Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery
You may not qualify if…
- ✕ 1. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function
- ✕ 2. Patients with active or any suspected infection (on the affected knee or systemic)
- ✕ 3. Previous partial knee replacement (unicompartimental, bicompartimental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
- ✕ 4. Patients with significant bone loss on femoral or tibial joint side
- ✕ 5. Current treatment for malignant and/or life-threatening non-malignant disorders
- ✕ 6. Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
- ✕ 7. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
- ✕ 8. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
Where it's recruiting
Source: ClinicalTrials.gov · NCT03048201 · last updated 2023-03-21