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Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL

NCT04244929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-05-31

No results posted yet for this study

Summary

Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee".

Primary endpoint

-Evaluation of the survival of the implant after 5 years of follow-up

Secondary endpoints

* Evaluation of the survival of the implant at 10 years of follow up.
* Evaluation of clinical and radiographic outcomes in Italian patients undergoing total knee replacement with the Persona Medial Congruent® implant with sacrifice or retention of the posterior cruciate ligament (PCL)

Conditions

  • Prosthesis Survival

Interventions

PROCEDURE

Total knee arthroplasty

Total knee arthroplasty using standard anterior approach.

DEVICE

Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining

Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained

DEVICE

Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice

Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Giulio Maria Marcheggiani Muccioli, MD, PhD · IRCCS Istituto Ortopedico Rizzoli

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2020-12-20
Completion
2021-03-01

Countries

  • Italy

Study Locations

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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 NCT04244929 on ClinicalTrials.gov