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A clinical study to evaluate the safety and performance of the Freedom Total Knee System Medial Congruent Liner used in patients undergoing knee replacement surgery

Freedom Total Knee System Medial Congruent Liner- An ambispective, single-arm, open label, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of Freedom Total Knee System Medial Congruent Liner - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/108103
Enrollment
84
Registered
2026-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants who underwent Freedom Total knee System MC Linear with aged above 18 years, irrespective of gender. 2.Participants willing and able to provide written Informed Consent by signing and dating the IRB or EC approved informed consent form (prospective phase) 3.The participants should be able to comply with protocol requirements and assessments.

Exclusion criteria

Exclusion criteria: 1. Participants unable or unwilling to provide written informed consent (prospective phase). 2. Participants who not underwent Freedom Total knee System MC Linear.

Design outcomes

Primary

MeasureTime frame
1.Range of Motion 2.Implant survivorship 3.ComplicationsTimepoint: 1.Time Frame: Pre and post-operative, through 1 year, 2 years, 3 years, 4 years and 5 years 2.Time Frame: Through 1 year, 2 years, 3 years, 4 years and 5 years 3.Time Frame: Pre and post-operative, through 1 year, 2 years, 3 years, 4 years and 5 years—

Secondary

MeasureTime frame
1.Revision rate 2.Radiographic Assessment 3.Pain score 4.VAS satisfaction 5. Length of hospital stay 6.Forgotten Joint Score 7. AE and SAETimepoint: 1.Time Frame: Through 1 year, 2 years, 3 years, 4 years and 5 years 2.Time Frame: Pre and Post Operative, Through 1 year, 2 years, 3 years, 4 years and 5 years 3.Time Frame: Pre and Post Operative, Through 1 year, 2 years, 3 years, 4 years and 5 years 4.Time Frame: Pre and post-operative and Discharge 5. Time Frame: Discharge 6. Time Frame: 2 years, 3 years, 4 years and 5 years 7.Time Frame: Pre and post-operative, through 1 year, 2 years, 3 years, 4 years and 5 years—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026