None listed
Conditions
Interventions
Control Intervention1: NIL: NIL
Control Intervention2: Serioss Bone Void filler: Serioss is a silk protein based osteo-conductive bone void filler for healing of bone defects. Patients have been imp
Sponsors
Serigen Mediproducts Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients enrolled in the Serioss Pilot clinical investigation Must be able and willing to provide written informed consent Must be willing to or likely to comply with all study requirements
Exclusion criteria
Exclusion criteria: Any patients not enrolled in the Serioss Pilot Clinical Investigation Patients with long standing steroid intake and known condition of Osteoporosis Patient participating in another interventional study that could interfere with it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate long-term safety of Serioss at 2 time points i.e. 3 years (+6 months) and 5 years (+ 6 months) in patients who participated in the pilot-clinical investigationTimepoint: 3 years (+6 months) and 5 years (+ 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish long-term safety of Serioss over the period of 5 years (+6 months) post implantation of Serioss in patients who participated in the pilot-clinical investigationTimepoint: 3 years & 5 years | — |
Countries
India
Contacts
Public ContactDr Swati Shukla
Serigen Mediproducts Pvt Ltd
Outcome results
None listed