Physica System Total Knee Replacement Registry Study
Limacorporate S.p.a · NCT03048201
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 800
- US sites recruiting
- 3
- Study start
- March 24, 2017
- Record last updated
- March 21, 2023
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Physica Kinematic Retaining Knee System; Physica Cruciate Retaining Knee System; Physica Posterior Stabilized Knee System; Physica Cruciate Retaining Knee System with LMC Liner
Conditions: Osteoarthritis, Knee; Traumatic Arthritis; Avascular Necrosis; Degenerative Joint Disease of Knee; Rheumatoid Arthritis; Deformity of Knee
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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):
including knee osteoarthritis, post-traumatic knee arthritis; or patients who are suffering from inflammatory arthritis; or patients that need correction of a functional deformity
- 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
- Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
- Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
- 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)
- Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
- Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Any psychiatric illness that would prevent comprehension of the details and nature of the study
- Patients currently participating in any other surgical intervention studies or pain management studies
- Female patients who are pregnant, nursing, or planning a pregnancy
Recruiting US locations
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
Rancho Mirage, CA 92270
Site contact: Izzy Nunez · 760-766-2540 · inunez@eisenhowerhealth.org
The Orthopedics Clinic
Daytona Beach, FL 32117
Site contact: Mark Gillespy, MD · 386-255-4596
Rush Castle Orthopaedics
Aurora, IL 60504
Site contact: Mark Schinsky, MD · 630-978-3800
Study contacts (from the official record)
- Fabiana Pavan · +390432945357 · Fabiana.Pavan@limacorporate.com
- Federica Azzimonti · federica.azzimonti@limacorporate.com
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