Actively Recruiting
Post-market Registry Study on the Physica System Total Knee Replacement
Led by Limacorporate S.p.a · Updated on 2023-03-21
800
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term performance of the commercially available Physica system for total knee replacement in patients with various knee conditions including osteoarthritis, traumatic arthritis, avascular necrosis, degenerative joint disease, rheumatoid arthritis, and knee deformity. This multi-center, prospective, non-randomized study aims to track implant survivorship for up to 10 years and assess clinical outcomes, patient-reported measures, and radiographic data to understand the effectiveness and durability of different Physica knee prosthesis configurations. Participants will receive one of several Physica system knee prosthesis types: Physica Kinematic Retaining (KR), Physica Cruciate Retaining (CR), Physica Posterior Stabilized (PS), or Physica Cruciate Retaining with LMC Liner. The choice of prosthesis is made by the investigators based on each patient's specific knee condition and standard clinical practice before surgery. An ancillary subgroup will also be followed for up to 5 years. Baseline clinical and radiographic evaluations occur before surgery and at 6 weeks post-operation, followed by ongoing assessments out to 10 years for the main study. During the study, participants will undergo regular clinical evaluations including the American Knee Society Score (KSS), patient-reported outcome measures, and radiographic imaging to monitor implant status and knee function. These assessments occur over a 10-year period, with safety and device performance closely tracked. Participants must comply with rehabilitation plans and scheduled follow-ups, providing valuable data on long-term implant survivorship and knee health after receiving the Physica system.
CONDITIONS
Brief Title
Physica System Total Knee Replacement Registry Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females of any race requiring total knee replacement and suitable for one of the Physica system configurations
- Age over 22 years (skeletally mature)
- Patients with non-inflammatory degenerative joint disease including knee osteoarthritis and post-traumatic knee arthritis, or inflammatory arthritis, or needing correction of functional knee deformity
- Suitable candidates for total knee replacement with undamaged and functional collateral ligaments
- Suitable candidates for Physica KR or CR systems with intact posterior cruciate ligament or Physica LMC with or without a functioning posterior cruciate ligament, or Physica PS for absent or non-functioning posterior cruciate ligament or severe knee instability
- Patients who understand the study and can comply with rehabilitation and follow-up visits
- Patients who have signed informed consent before surgery
You will not qualify if you...
- Severe knee instability due to absent or non-functioning collateral ligaments
- Active or suspected infection in the affected knee or systemically
- Previous partial knee replacement, patellectomy, or high tibial osteotomy
- Significant bone loss on femoral or tibial joint sides
- Current treatment for malignant or life-threatening non-malignant disorders
- Known allergy or hypersensitivity to implant materials
- Severe vascular insufficiency in lower limbs affecting evaluation
- Compromised bone stock from disease, infection, or prior implants
- Systemic or metabolic disorders causing progressive bone deterioration
- Any disease or dependency affecting prosthesis performance
- Significant pathology affecting study evaluation (e.g., primary osteoporosis, haemophilia, osteomyelitis)
- Neurological or musculoskeletal disorders affecting gait or recovery
- Neuromuscular or neurosensory deficits limiting device assessment
- History of infection in the affected joint or systemic infection
- Psychiatric illness preventing understanding of study details
- Participation in other surgical or pain management studies
- Female patients who are pregnant, nursing, or planning pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total knee replacement surgery with one of the Physica System knee prostheses, as decided by their surgeon based on clinical evaluation.
1 visit (in-person)
Duration - Up to 10 years
Participants attend follow-up visits for clinical and radiographic assessments to monitor recovery and implant performance.
Scheduled visits including a 6-week post-operative visit and periodic follow-ups up to 10 years
Trial Site Locations
Total: 5 locations
1
Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg
Rancho Mirage, California, United States, 92270
Actively Recruiting
2
The Orthopedics Clinic
Daytona Beach, Florida, United States, 32117
Actively Recruiting
3
Rush Castle Orthopaedics
Aurora, Illinois, United States, 60504
Actively Recruiting
4
Syracuse Orthopedic Specialists
Syracuse, New York, United States, 13214
Completed
5
Joint Reconstructive Specialist
Oklahoma City, Oklahoma, United States, 73159
Completed
Research Team
F
Fabiana Pavan
F
Federica Azzimonti
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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