NCT03048201 Physica System Total Knee Replacement Registry Study
| NCT ID | NCT03048201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Limacorporate S.p.a |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2017-03-24 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 800 participants in total. It began in 2017-03-24 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 9. Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant 10. Any concomitant disease and dependence that might affect the performance of the implanted prosthesis 11. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis) 12. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation 13. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device 14. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint 15. Any psychiatric illness that would prevent comprehension of the details and nature of the study 16. Patients currently participating in any other surgical intervention studies or pain management studies 17. Female patients who are pregnant, nursing, or planning a pregnancy
Contact & Investigator
Fabiana Pavan
STUDY DIRECTOR
Limacorporate S.p.a
Frequently Asked Questions
Who can join the NCT03048201 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03048201 currently recruiting?
Yes, NCT03048201 is actively recruiting participants. Contact the research team at Fabiana.Pavan@limacorporate.com for enrollment information.
Where is the NCT03048201 trial being conducted?
This trial is being conducted at Rancho Mirage, United States, Daytona Beach, United States, Aurora, United States, Syracuse, United States and 1 additional location.
Who is sponsoring the NCT03048201 clinical trial?
NCT03048201 is sponsored by Limacorporate S.p.a. The principal investigator is Fabiana Pavan at Limacorporate S.p.a. The trial plans to enroll 800 participants.