Health Condition 1: M169- Osteoarthritis of hip, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants aged equal to or above 18 years, irrespective of gender, scheduled to undergo implantation of a Total Hip Arthroplasty by using Dual Mobility. 2.Participants who have undergone treatment using the Dual Mobility for non inflammatory degenerative joint disease, including osteoarthritis, post-traumatic arthritis, vascular necrosis and rheumatoid arthritis. 3.Participants with congenital hip dysplasia. 4.Participants with acute traumatic fracture of the femoral head or neck Participants with certain cases of Ankylosis. 5.Participants with dislocation of the hip. 6.Participants who require correction of functional deformity. 7.Participants who require revision of failed joint reconstruction or treatment. 8.Participants who require treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur. 9.Participant is willing to undergo all study related procedures and follow up requirements. 10.Participants willing and able to provide written Informed Consent by signing and dating the IRB or EC approved informed consent form to participate in this post-market clinical follow up study.
Exclusion criteria
Exclusion criteria: 1.Participants who have not been undergone treatment using the Dual Mobility. 2.Participants having active local or systemic infection. 3.Participants having poor bone quality or bone stock that is inadequate for support or fixation of the components. 4.Participants having loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. 5.Any condition that may interfere with survival of the implants such as Charcots disease or Pagets disease. 6.Skeletally immature participants. 7.Participants having metabolic disorder which may impair bone formation. 8.Participants having sensitivity to the implant material. 9.Participants unable or unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Implant Survivorship and Revision rate and Adverse Events and Harris Hip ScoreTimepoint: Preoperative, Intraoperative, Through Discharge, 6 weeks, 3 months, 6 months, 1 year, 5 years, 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Range of Motion 2.HHS 3.WOMAC 4.Radiograhic Analysis 5.Length of Hospital Stay 6.HOOS 7.Post Operative Complication 8.SF 12 9.Laboratory AssessmentsTimepoint: Baseline, Through Discharge, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years, 10 years | — |
Countries
India
Contacts
Public ContactDr KiranKumar Shetty
Meril Life Sciences Pvt Ltd
Outcome results
None listed