Post Marketinng Surveillance to Evaluate implant survivorship and performance of the FreedomÂ® Total Knee System in Total Knee Arthroplasty

Phase 4

Conditions: Health Condition 1: M179- Osteoarthritis of knee, unspecified

Registration Number: CTRI/2016/11/007455

Lead Sponsor: Meril Life Sciences India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

1.Subject is male or non-pregnant female

aged 18 years or older at the time of

study.

2.Subject is willing and able to provide

written Informed Consent by signing and

dating the IRB or EC approved Informed

Consent Form.

3.Subject is a candidate for a total knee

arthroplasty

4.Subject is willing and able to comply

with postoperative scheduled clinical and

radiographic evaluations

Exclusion Criteria

1.Subject with a BMI greater than or equal

to 40

2.Subject with an active infection within

the affected knee joint

3.Subject with neuromuscular or

neurosensory deficiency that may limit

ability of the patient to evaluate the

safety and efficacy of the device

4.Subject with a known sensitivity to

device materials

5.Subject is unwilling or unable to sign

the Informed Consent Document.

6.Subject with short Life expectancy less

than 5 years (e.g. Cancer, HIV/AIDS)

7.Subject with history of deep vein

thrombosis or other thrombotic disorders.

8.Subject with conditions such as

Parkinsonism, loco motors ataxia, spinal

scoliosis or kyphosis, stroke etc. that

would affect their loco motors stability

and interfere with assessment of Range of

Motion of the target Knee.

9.Subject who, in consideration of treating

doctor, would not be suitable for

compliance of the follow up

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Implant Survivorship <br/ ><br> <br/ ><br>2.Cumulative Revision <br/ ><br> RateTimepoint: 6 weeks, 6 months, 1 year, 3 years, 5 years , 7 years and 10 years <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Knee Society Score <br/ ><br>2.WOMAC (Western Ontario <br/ ><br> and McMaster <br/ ><br> Universities <br/ ><br> Osteoarthritis) Pain <br/ ><br>3.Range of Motion <br/ ><br>4.SF-36 Questionnaire <br/ ><br> Short Form Health <br/ ><br> Survey questionnaire) <br/ ><br>5.Radio graphic Analysis <br/ ><br>6. Adverse EventsTimepoint: Pre-Op, 6 weeks, 6 months, 1year, 3, 5, 7 and 10 years