RecruitingNot applicable

Physica System Total Knee Replacement Registry Study

Post-market Registry Study on the Physica System Total Knee Replacement

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These patients will follow the same study schedules as the main study, but follow-up is only up to 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (5)

CA

FL

IL

NY

OK