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New treatment option for Osteoarthritis, Knee
Official title Physica System Total Knee Replacement Registry Study
ClinicalTrials.gov ID: NCT03048201
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rancho Mirage, California, United States
- Daytona Beach, Florida, United States
- Aurora, Illinois, United States
- Syracuse, New York, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rancho Mirage, California, United States; Daytona Beach, Florida, United States; Aurora, Illinois, United States; Syracuse, New York, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.