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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
Must not have
Patients with significant bone loss on femoral or tibial joint side
Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
I have arthritis or need surgery to correct a knee deformity.
Select...
My knee's side ligaments are healthy and working well.
Select...
I am a candidate for knee replacement and my knee's condition matches the specific requirements.
Select...
I am over 22 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have significant bone loss in my leg joints.
Select...
My leg circulation problems could affect the study's tests.
Select...
My bones are too weak to support a new implant due to disease, infection, or previous implants.
Select...
I have a condition that worsens my bone health, affecting implants.
Select...
I am pregnant, nursing, or planning to become pregnant.
Select...
I am currently being treated for a serious or life-threatening illness.
Select...
My knee is very unstable because of damaged or non-functioning side ligaments.
Select...
I do not have an active infection in my knee or anywhere else in my body.
Select...
I have had surgery on part of my knee or a procedure to realign or remove my kneecap.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
26 Previous Clinical Trials
2,284 Total Patients Enrolled
4 Trials studying Osteoarthritis
391 Patients Enrolled for Osteoarthritis
Laura SanchezStudy DirectorLimacorporate S.p.a
Fabiana PavanStudy 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 CR, Physica KR, 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
~325 spots leftby Mar 2030
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