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

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.

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis; Knee Osteoarthritis; Post-traumatic Osteoarthritis
• Intervention / Treatment: Device: Freedom® Total Knee System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vikas Salgotra, M.Phil; Phone Number: 91 8879063803; Email: vikas.salgotra@merillife.com
• Study Contact Backup: Name: Ashok Thakkar, Ph.D; Phone Number: 91 9879443584; Email: ashok.thakkar@merillife.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Freedom® Total Knee System; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 1 year and 3 years
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.	At 1 year and 3 years
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	At 1 year and 3 years

Collaborators and Investigators

• Sponsor: Meril Life Sciences Pvt. Ltd.
• Investigators: Principal Investigator: Prof. Hemant Pandit, FRCS (Orth), Chapel Allerton Hospital and University of Leeds

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2032

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MLSIPL/ Freedom® 450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes