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Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis

NCT04033588 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2020-10-05

No results posted yet for this study

Summary

A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of approximately 450 subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis at upto 15 centers in the United Kingdom (UK). The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Freedom® Total Knee System used in total knee replacement. Subjects must meet all the study inclusion / exclusion criteria before enrolment in the study. Subjects will be requested to attend out-patients clinic for clinical follow-up (CFU) or approached for telephonic follow-up (TFU) post-operatively as mentioned below.

Clinical \& Telephonic Follow-up details:

* 6-8 weeks ± 1week (Clinical follow-up)
* 1 year ± 1 month (Clinical follow-up)
* 3 years ± 6 months (Clinical follow-up)
* 5 years ± 6 month (Clinical follow-up (optional) / Telephonic follow-up)
* 10 years± 6 month (Clinical follow-up (optional) / Telephonic follow-up)

Conditions

Interventions

DEVICE

Freedom® Total Knee System

To evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis.

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Prof. Hemant Pandit, FRCS (Orth) · Chapel Allerton Hospital and University of Leeds

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-09-01
Completion
2032-09-01
FDA Device
Yes

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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 NCT04033588 on ClinicalTrials.gov