Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2017-03-24
2030-03-31
Brief Summary
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Detailed Description
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This is a multi-centre, prospective, non-randomized study.
Subjects will be implanted with one of the following configurations of the Physica system: Physica KR (Kinematic Retaining), Physica CR (Cruciate Retaining) or Physica PS (Posterior Stabilized). The assignment of any patient involved in the study is determined by the aetiology preoperatively evaluated by the Investigator and falls within current practice. The decision to use a specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the patient in the study.
For the ancillary subgroup, investigators currently contributing to the primary patient group can also enroll additional patients to the ancillary subgroup. 3 existing sites and 2 additional sites are planned to be added to contribute to the additional 300 patients to be enrolled. These patients will follow the same study schedules as the main study, but follow-up is only up to 5 years.
Baseline measurements (pre-operative clinical analysis and radiographic analysis at 6-week FU) will serve as internal control term during the assessment of post-surgery data out to 10 years.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Physica KR
Subjects that receive the Physica Kinematic Retaining Knee System
Physica Kinematic Retaining Knee System
Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Physica CR
Subjects that receive the Physica Cruciate Retaining Knee System
Physica Cruciate Retaining Knee System
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Physica PS
Subjects that receive the Physica Posterior Stabilized Knee System
Physica Posterior Stabilized Knee System
Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
Physica CR with LMC Liner
Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner
Physica Cruciate Retaining Knee System with LMC Liner
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Interventions
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Physica Kinematic Retaining Knee System
Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
Physica Cruciate Retaining Knee System
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Physica Posterior Stabilized Knee System
Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
Physica Cruciate Retaining Knee System with LMC Liner
Total knee prosthesis with posterior cruciate ligament (PCL) preservation
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
ALL
No
Sponsors
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Limacorporate S.p.a
INDUSTRY
Responsible Party
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Principal Investigators
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Fabiana Pavan
Role: STUDY_DIRECTOR
Limacorporate S.p.a
Locations
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Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
Rancho Mirage, California, United States
The Orthopedics Clinic
Daytona Beach, Florida, United States
Rush Castle Orthopaedics
Aurora, Illinois, United States
Syracuse Orthopedic Specialists
Syracuse, New York, United States
Joint Reconstructive Specialist
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Mark Gillespy, MD
Role: primary
Sherri Zicker
Role: backup
Mark Schinsky, MD
Role: primary
Renee Bergstrom
Role: backup
Other Identifiers
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K-11
Identifier Type: -
Identifier Source: org_study_id
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