Health Condition 1: S024- Fracture of malar, maxillary and zygoma bones Health Condition 2: S026- Fracture of mandible Health Condition 3: S020- Fracture of vault of skull Health Condition 4: S021- Fracture of base of skull Health Condition 5: S022- Fracture of nasal bones Health Condition 6: S023- Fracture of orbital floor
Conditions
Interventions
Intervention1: Seribo Systems CMF Bone Plates and screws: Seribo Systems CMF Bone plates and screws are medical devices used in craniomaxillofacial reconstruction to hold fracture fragments together d
Sponsors
OsteoForge MedTech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants aged 06 years to 65 years Those who voluntarily agreed to participate in clinical trials and were willing to comply with the study protocol Participants with any one of the following Minimally displaced and undisplaced cranial fractures Minimally displaced and undisplaced maxillary fractures Minimally displaced and undisplaced Zygomaticomaxillary fractures Minimally displaced and undisplaced mandible fractures
Exclusion criteria
Exclusion criteria: Complex and comminuted Cranial fractures Complex and comminuted maxillary displaced fractures Complex and comminuted zygomaticomaxillary fractures Complex and comminuted mandibular fractures Unfavorable fractures Participants with uncontrolled metabolic diseases Participants with heart disease or liver dysfunction Participants with blood disease Participants who cannot stop taking steroids, anti-thrombotic, or anticoagulants before surgery Drug abusers, alcoholics and Smokers Women who are pregnant, breast feeding or have a pregnancy plan during the clinical trial period. Investigator judges that participation in the clinical trial is inappropriate due to safety concerns or other medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the functional jaw activity at 3 month post operation To evaluate the safety of the Seribo Systems CMF bone plates and screws at 5 days, 15 days, 1 month and 3 months post-operation Timepoint: 5 and 15 days, 1 and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the long-term safety of the implants for 24 months post-surgery To monitor and capture the adverse events To evaluate the performance of the plates and screws through bone consolidation at 3 and 6 months post operationTimepoint: 3 6 12 18 24 months | — |
Countries
India
Contacts
Public ContactDr Syam Kumar Y
OsteoForge MedTech Private Limited
Outcome results
None listed