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Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis (Freedom®450)

Primary Purpose

Knee Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Freedom® Total Knee System

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects aged between 18 years and 75 years.
Subjects who require unilateral knee prosthesis and have been evaluated as appropriate candidates for a total knee replacement by the investigator.
Subjects suffering from severe knee joint pain and loss of mobility due to rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis.
Subjects, who in the opinion of the investigator are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow ups.
Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria:

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
Subjects who are known drug or alcohol abuse or with psychological disorders that could affect follow-up care or treatment outcomes.
Subject with a known sensitivity to device materials.
Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).
Subjects with a BMI of 40 or above.
Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed or have any other significant medical illness judged by investigator to exclude from study.
Subject with neuromuscular or neurosensory deficiency that may limit ability of the patient to evaluate the safety and efficacy of the device.
Female subjects who are pregnant or lactating.
Subjects who have previously undergone total or unicondylar knee replacement, high tibial osteotomy, ligament reconstruction, open reduction internal fixation (ORIF) or with previous fracture in the ipsilateral knee joint.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Freedom® Total Knee System

Arm Description

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 United Kingdom

Outcomes

Primary Outcome Measures

Implant Survivorship Kaplan-Meier estimates of survivorship for all components

Implant survivor-ship will be established by using revision surgery on the operated knee as implant failure.

Secondary Outcome Measures

Oxford Knee Score which consists of 12 questions

Oxford Knee Score is a patient-reported validated outcome measure scoring from 0 - 48. It consists of 12 questions related to patient's own perception of pain and function in the knee being evaluated. Higher the score better the functioning of the knee.

Range of Motion using a standard goniometer

Range of motion will be assessed using a standard goniometer. It will measure the angle between maximum extension and maximum flexion that a patient can achieve in the operated knee.

Knee Society Score

This score consists of points given for pain, range of motion, and stability. It Consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs.Score range of the KSS is from 0 to 100 points for each portion, with higher scores indicating better outcome

Full Information

NCT ID

NCT04033588

First Posted

January 23, 2019

Last Updated

October 1, 2020

Sponsor

Meril Life Sciences Pvt. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04033588

Brief Title

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

Acronym

Freedom®450

Official Title

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 United Kingdom.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

September 1, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meril Life Sciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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)

Detailed Description

At all the clinical/telephonic follow-up visits i.e. at 8 weeks ± 1week, 1 year ± 1 month, 3 years ± 6 months, 5 years ± 6 months and 10 years ± 6 months implant survivorship and vital signs such as weight, heart rate etc including blood pressure will be recorded. Physical examination, lab measurements (optional), Radiographic assessment, concomitant medication/surgery and AE/SAE should be recorded. Also at all clinical follow ups OKS, KSS, range of motion will be recorded. The post-operative radiographic evaluations will be conducted at 0-8 weeks ± 1 week (which is considered as standard of care), 1 year ± 1 month, 3 years ± 6 months and optionally at 5 years ± 6 months, 10 years ± 6 months and Unscheduled visits, if required. The unscheduled visit is expected in some patients based on the fact that such patients might prone to complications like surgical site infections, venous thrombotic events, acute blood loss causing anaemia, nerve injury, and pain unresponsive to oral analgesics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

A prospective, multi-centre, non-comparative, post-market clinical follow-up study

Masking

None (Open Label)

Allocation

N/A

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Freedom® Total Knee System

Arm Type

Other

Arm Description

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 United Kingdom

Intervention Type

Device

Intervention Name(s)

Freedom® Total Knee System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Implant Survivorship Kaplan-Meier estimates of survivorship for all components

Description

Implant survivor-ship will be established by using revision surgery on the operated knee as implant failure.

Time Frame

At 3 years

Secondary Outcome Measure Information:

Title

Oxford Knee Score which consists of 12 questions

Description

Time Frame

At 1 year and 3 years

Title

Range of Motion using a standard goniometer

Description

Range of motion will be assessed using a standard goniometer. It will measure the angle between maximum extension and maximum flexion that a patient can achieve in the operated knee.

Time Frame

At 1 year and 3 years

Title

Knee Society Score

Description

Time Frame

At 1 year and 3 years

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects aged between 18 years and 75 years. Subjects who require unilateral knee prosthesis and have been evaluated as appropriate candidates for a total knee replacement by the investigator. Subjects suffering from severe knee joint pain and loss of mobility due to rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis. Subjects, who in the opinion of the investigator are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow ups. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. Exclusion Criteria: Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. Subjects who are known drug or alcohol abuse or with psychological disorders that could affect follow-up care or treatment outcomes. Subject with a known sensitivity to device materials. Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints). Subjects with a BMI of 40 or above. Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed or have any other significant medical illness judged by investigator to exclude from study. Subject with neuromuscular or neurosensory deficiency that may limit ability of the patient to evaluate the safety and efficacy of the device. Female subjects who are pregnant or lactating. Subjects who have previously undergone total or unicondylar knee replacement, high tibial osteotomy, ligament reconstruction, open reduction internal fixation (ORIF) or with previous fracture in the ipsilateral knee joint.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vikas Salgotra, M.Phil

Phone

91 8879063803

vikas.salgotra@merillife.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ashok Thakkar, Ph.D

Phone

91 9879443584

ashok.thakkar@merillife.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Hemant Pandit, FRCS (Orth)

Organizational Affiliation

Chapel Allerton Hospital and University of Leeds

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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