Current Clinical Trials

Physica System Total Knee Replacement Registry Study
  1. Erik Schnaser, MD
    Erik Schnaser, MD
  2. for people 22 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started March 2019
  5. Erik Schnaser, MD
  6. Accepting new patients

Description

Summary

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.

Official Title

Post-market Registry Study on the Physica System Total Knee Replacement

Detailed Description

This is a post-market registry study; the study device is FDA cleared and used according to the intended use. 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 fall... more
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This is a post-market registry study; the study device is FDA cleared and used according to the intended use. 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.

Keywords

Osteoarthritis, Knee

Eligibility

for people 22 Years and up
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 undama... more
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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

Lead Scientists at Eisenhower Health

Erik Schnaser, MD
Erik Schnaser, MD. is a fellowship-trained hip and knee replacement surgeon. He specializes in adult hip and knee disorders including pre-arthritic and arthritic conditions. He has a special interest in patient-specific instrumentation, surgical navigation, robotic surgery, as well as taking care of and revising patients with failing or failed total joint replacements. His surgical skill set includes, but is not limited to total hip replacements, total knee replacements, partial knee replacement... more
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Erik Schnaser, MD. is a fellowship-trained hip and knee replacement surgeon. He specializes in adult hip and knee disorders including pre-arthritic and arthritic conditions. He has a special interest in patient-specific instrumentation, surgical navigation, robotic surgery, as well as taking care of and revising patients with failing or failed total joint replacements. His surgical skill set includes, but is not limited to total hip replacements, total knee replacements, partial knee replacements, knee arthroscopies, total hip revisions, total knee revisions, and lower extremity traumatic injuries.

“The great thing about specializing in hip and knee replacements is that these procedures truly have the ability to give patients their lives back. Few careers are this rewarding.”

Dr. Schnaser is originally from Carson City, Nevada and is the son of an orthopedic surgeon. He received his Bachelors of Science in Biochemistry at the University of Southern California and then attended medical school at the University of Nevada School of Medicine. He then completed a surgical internship and an orthopedic surgical residency at Case Western Reserve School of Medicine. Following his residency, Dr. Schnaser completed a fellowship in adult hip and knee reconstruction at the Hospital for Special Surgery in New York City.

Dr. Schnaser is particularly interested in researching clinical outcomes after hip and knee replacements. He believes that patient-specific instrumentation, navigation, and robotics have the potential to increase patient satisfaction and clinical outcomes following joint replacement surgery. He has given over 20 national and international presentations stemming from his research, has authored several peer-reviewed publications, and has written book chapters on the subject of joint replacement surgery. He was a member of the America Academy of Orthopedic Surgeon’s Research Development Committee and has spent time on Capitol Hill in order to ensure that the National Institutes of Health continues to receive research support for musculoskeletal conditions.

Publications:

To view a listing of Dr. Schnaser's publications, click here.

Co-Investigators

  1. Ghassan Boghosian, DO

Clinical Study Details

  1. Accepting new patients
  2. study started March 2019
  3. Interventional
  4. April 04, 2024