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Prosthetic Device

Total Knee Replacement for Osteoarthritis

N/A
Recruiting
Research Sponsored by Limacorporate S.p.a
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients suffering from non-inflammatory degenerative joint disease (NIDJD) including knee osteoarthritis, post-traumatic knee arthritis, or inflammatory arthritis, or patients needing correction of a functional deformity
Suitable candidates for TKR who have undamaged and functional collateral ligaments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial will look at the long-term success of a particular type of hip implant, assessing clinical outcomes and patient reported satisfaction.

Who is the study for?
This trial is for adults over 22 with knee issues like osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or deformities needing a total knee replacement. Candidates must be able to follow the study's rehab program and attend all visits. Exclusions include poor bone quality, active infections, certain past surgeries or conditions affecting bone health, pregnancy, and severe instability of the knee.Check my eligibility
What is being tested?
The Physica System Total Knee Replacement Registry Study aims to track long-term performance (up to 10 years) of different Physica knee implants in patients with various types of knee problems. It will collect data on implant survival rates as well as patient-reported outcomes and x-ray results.See study design
What are the potential side effects?
While specific side effects are not listed for this registry study, typical risks associated with total knee replacement may include pain at the surgery site, infection risk around the implant area, blood clots in leg veins or lungs after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have arthritis or need surgery to correct a knee deformity.
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My knee's side ligaments are healthy and working well.
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I am a candidate for knee replacement and my knee's condition matches the specific requirements.
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I am over 22 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implant Survivorship
Secondary outcome measures
American Knee Society Score (KSS) 2011
Patient-Reported Outcome Measures (PROMs)
Radiographic Evaluation

Trial Design

4Treatment groups
Experimental Treatment
Group I: Physica PSExperimental Treatment1 Intervention
Subjects that receive the Physica Posterior Stabilized Knee System
Group II: Physica KRExperimental Treatment1 Intervention
Subjects that receive the Physica Kinematic Retaining Knee System
Group III: Physica CR with LMC LinerExperimental Treatment1 Intervention
Subjects that receive the Physica Cruciate Retaining Knee System with LMC Liner
Group IV: Physica CRExperimental Treatment1 Intervention
Subjects that receive the Physica Cruciate Retaining Knee System

Find a Location

Who is running the clinical trial?

Limacorporate S.p.aLead Sponsor
23 Previous Clinical Trials
2,045 Total Patients Enrolled
3 Trials studying Osteoarthritis
342 Patients Enrolled for Osteoarthritis
Fabiana PavanStudy DirectorLimacorporate S.p.a
Laura SanchezStudy DirectorLimacorporate S.p.a

Media Library

Physica Cruciate Retaining Knee System (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT03048201 — N/A
Osteoarthritis Research Study Groups: Physica KR, Physica CR, Physica PS, Physica CR with LMC Liner
Osteoarthritis Clinical Trial 2023: Physica Cruciate Retaining Knee System Highlights & Side Effects. Trial Name: NCT03048201 — N/A
Physica Cruciate Retaining Knee System (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03048201 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT03048201 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants in this research endeavor?

"Limacorporate S.p.a, the donor of this research project, requires 500 volunteers that satisfy the eligibility criteria to effectively study their proposed intervention. Rush Castle Orthopaedics in Aurora, Illinois and Eisenhower Desert Orthopedics Center - Harry and Diane Rinker Bldg in Rancho Mirage, California are two sites at which they will be gathering data from participants."

Answered by AI

Are there still open slots available for individuals interested in participating in this research?

"Observations on clinicaltrials.gov assert that this trial is presently enrolling suitable participants. The trial, which was originally established in March 2017, has been altered as recently as April 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
The Orthopedics Clinic
Rush Castle Orthopaedics
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

joint pain in left knee. and hip. I have tried 2 different injections, PT, and NSAIDs and still have pain in my Left knee that has changed my quality of life. I am hoping to get relief and get back to life as I know it, and be active in sports again.
PatientReceived 1 prior treatment
~366 spots leftby Mar 2030