Physica System Total Knee Replacement Registry Study
Recruiting
N/AInterventional Study
Osteoarthritis, KneeTraumatic ArthritisAvascular NecrosisDegenerative Joint Disease of KneeRheumatoid ArthritisDeformity of Knee
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
Limacorporate S.p.a · Industry
Who this trial is looking for
This trial is looking for adults needing a total knee replacement due to various knee conditions. Participants will receive a special knee implant and will be followed up for up to 10 years to monitor its performance and recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I need a total knee replacement.
I am at least 22 years old.
I have knee osteoarthritis or another type of joint disease.
I have functional ligaments in my knee.
I am willing to follow rehabilitation instructions.
I understand the study and have signed the consent form.
You may not be able to join if
I have severe instability in my knee.
I have an active infection in my body.
I have had any previous knee replacement surgery.
I have significant bone loss in my knee.
I have a serious illness that could interfere with the study.
I am allergic to the implant materials.
I have serious blood flow issues in my legs.
I have a history of severe joint infections.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 k…
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
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