Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.The subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form. 2.In the case of a subject and LAR being illiterate a literate impartial witness is required during consenting. 3.If the subject is not able to write on behalf of the subject the subjects LAR (Legally acceptable representative) can fill out the informed consent. 4.The subject is willing and able to comply with postoperative scheduled clinical evaluations. 5.Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. 6.The inclusion criteria for the use of MISSO as a stereotaxic device for knee arthroplasty include surgeons seeking assistance in preoperative planning using patients medical diagnostic images and requiring orientation and reference information during intraoperative procedures. 7.Only the participating surgeons who oversee the utilization of surgical tools will execute the preoperative surgical plan while using MISSO as a stereotaxic device for knee arthroplasty. 8.The subject should have attained at least the adult age 18 years at the time of the surgery.
Exclusion criteria
Exclusion criteria: 1.Without informed consent, the subject is not eligible for the study 2. If the robotic system of any other brand is used, the subject shouldnâ??t be included in the study 3. Individuals with any active infections are excluded. 4. Individuals exhibiting skeletal immaturity are not considered. 5. Individuals who can be in situations wherein strong infrared sources or infrared reflectors are present in the vicinity of the trackers are excluded. 6. Implants that are not compatible with the system are excluded. 7. Pregnant ladies shall be excluded from the study. 8. Subjects with a short life expectancy of fewer than 1 year 9. Subject with a known sensitivity to device materials 10. Subjects with neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device 11. Subjects with a history of deep vein thrombosis or other thrombotic disorders 12. Subjects with conditions such as severe Parkinsonism and locomotor ataxia that would affect their locomotor stability and interfere with the assessment of the Range of Motion of the target knee 13. Subjects with severe osteoporosis (T score greater than -3) shall be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Component Alignment - TKA 2. Component Alignment-TKA 3. Component Alignment - TKA 4. Bonecutaccuracy 5. Intra-Operative Complications 6. Post-resection Soft Tissue Release(STR)and reosteotomy 7. Accuracy of total knee arthroplasty component placement 8. Adverse EventsTimepoint: 1. Time Frame: Post-operative (Day-0) 2. TimeFrame:3months 3. Time Frame: 3 weeks,3months ,6months, 1 year 4. Time Frame :Pre-Cut and Intraoperative measurements 5. Time Frame: Intra-operative 6. TimeFrame:Intra-operative 7. TimeFrame:PreoperativePlan,3weeks,3months,6months, 1 year 8. Time Frame: Postoperative, 3 weeks, 3months, 6months, 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Radiographic assessment of Limb Alignment 2.Radiographic assessment of prosthesisposition 3.Radiographic assessment for MISSO ROBOTIC SYSTEM registration 4.Operative time 5.Alteration in the Hemoglobin Level 6.Percentage of Subjects with Postoperative Coronal Limb Alignment of more than 3 from the Planned Coronal Limb Alignment 7.Change in the objective Knee Society Score from the baseline 8.Severe & rare complications 9.Radiographic assessment 10.Adverse Events 11.Range of Motion 12.SF-12 Questionnaire Timepoint: Time Frame: Pre-operative, Intra-operative,3 Weeks, 3 Months, 6 month & 1 Year | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed