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Physica System Total Knee Replacement Registry Study

NCT03048201 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-03-21

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Traumatic Arthritis
  • Avascular Necrosis
  • Degenerative Joint Disease of Knee
  • Rheumatoid Arthritis
  • Deformity of Knee

Interventions

DEVICE

Physica Kinematic Retaining Knee System

Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation

DEVICE

Physica Cruciate Retaining Knee System

Total knee prosthesis with posterior cruciate ligament (PCL) preservation

DEVICE

Physica Posterior Stabilized Knee System

Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.

DEVICE

Physica Cruciate Retaining Knee System with LMC Liner

Total knee prosthesis with posterior cruciate ligament (PCL) preservation

Sponsors & Collaborators

  • Limacorporate S.p.a

    lead INDUSTRY

Principal Investigators

  • Fabiana Pavan · Limacorporate S.p.a

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2030-03-31
Completion
2030-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048201 on ClinicalTrials.gov