Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: PEEK-OPTIMA: Femoral Component in total knee replacement system (The study is first in man and will be implanted once at the entire life time), study duration: 6 weeks (�± 15 days ),
Sponsors
Meril Life Sciences India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects aged 50 years of age or older and less than 75 years of age ( >50 and 2.Subjects who require uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator. 3.Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis. 4.Subjects with the deformity of Varus with the anatomical limb alignment of 0-20 degrees 5.Subjects who already have TKR done in other knee with a standard implant (must be compatible for the MRI evaluation as per the MRI protocol of the current study) 6.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-up. 7.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
Exclusion criteria: 1.Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. 2.Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. 3.Subjects who have participated in a clinical study with an investigational product in the last 6 months. 4. Subjects with other significant disabling problems from the muscular- skeletal system other than in the knees (i.e. muscular dystrophy, polio, neuropathic joints). 5.Subject with the known osteoporosis (BMD T-Score below -2.5 and/or previous history of fracture related to osteoporosis. (severe osteoporosis as per WHO definition) 6.Subjects with a Body Mass Index (BMI) of 32 or above. 7.Subjects with a current or active history of malignancy, active or suspected infection, Pagetââ?¬•s disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus. 8. Subjects who have a neuromuscular or neurosensory deficit. Female subjects who are pregnant or lactating. 9.Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.ââ?°Â¥ 10.Subjects with a fixed flexion deformity of over 20 degrees. 11.Subjects with recurvatum (definition: hyperextension ââ?°Â¥5 degrees 12.Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, open reduction and internal fixation (ORIF) or with previous fracture in the ipsilateral knee joint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score (KSS)Timepoint: At 6 months post-treatment compared to pre-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Procedural success 2.KSS Knee scores and KSS Function scores 3. SF-36, Oxford Knee Score and WOMAC 4.Stability of the device through radiographic analysis 5.Stability of the device through MRI analysis 6.Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery 7. Survivorship analysis of the device Timepoint: 1. At the time of implantation 2. KSS Knee scores at 6 weeks, 12 and 24 months post-treatment and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment. 3.At 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment 4.At prior to discharge, 6 weeks, 6, 12 and 24 months post-treatment 5.At 6 weeks, 6, 12 and 24 months post-treatment 6. Survivorship analysis of the device at 12 and 24 months and annually thereafter | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Deenanath Mangeshkar Hospital & Research Center
Outcome results
None listed