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

NCT04033588 | Not Yet Recruiting FDA Device

• 1 other identifier: MLSIPL/ Freedom® 450
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Knee Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Oxford Knee Score which consists of 12 questions

  At 1 year and 3 years

• Range of Motion using a standard goniometer

  At 1 year and 3 years

• Knee Society Score

  At 1 year and 3 years

Study Arms (1)

Freedom® Total Knee System

OTHER

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

Interventions

Freedom® Total Knee System DEVICE

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.

Freedom® Total Knee System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meril Life Sciences Pvt. Ltd.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Prof. Hemant Pandit, FRCS (Orth)

  Chapel Allerton Hospital and University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikas Salgotra, M.Phil

CONTACT

91 8879063803; vikas.salgotra@merillife.com

Ashok Thakkar, Ph.D

CONTACT

91 9879443584; ashok.thakkar@merillife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: July 26, 2019
• Study Start: January 1, 2021
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2032
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share