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NCT03048201 · Limacorporate S.p.a

Physica System Total Knee Replacement Registry Study

What this 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 treatment group$1, from baseline to 5-year follow-up.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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

Where

  • Rancho Mirage, California
  • Daytona Beach, Florida
  • Aurora, Illinois
  • Syracuse, New York
  • Oklahoma City, Oklahoma

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Mar 21, 2023 · Source of record for eligibility and locations

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1 of 800 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Rancho Mirage

California

Location available
RECRUITING

Daytona Beach

Florida

Location available
RECRUITING

Aurora

Illinois

Location available
COMPLETED

Syracuse

New York

Location available
COMPLETED

Oklahoma City

Oklahoma

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Osteoarthritis, Knee Treatment in Rancho Mirage?

Join others in California exploring innovative treatment options through clinical research

Osteoarthritis, Knee Treatment Options in Rancho Mirage, California

If you're searching for Osteoarthritis, Knee treatment in Rancho Mirage, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Rancho Mirage, Daytona Beach, Aurora and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Osteoarthritis, Knee. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 800 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Osteoarthritis, Knee?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Osteoarthritis, Knee

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Osteoarthritis, Knee Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT03048201. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.