Health Condition 1: S623- Fracture of other and unspecifiedmetacarpal bone
Conditions
Interventions
Intervention1: Hand plate system - Medical Implant: Plates will be implanted only once and will be there for max. 12 Months
Control Intervention1: Not applicable: Not applicable
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Both male and female above 18 years to 65 years 2 Patients presenting to Orthopaedic emergency or OPD with Hand Fracture which need internal fixation will be included in the study
Exclusion criteria
Exclusion criteria: 1 Any past or present evidence of infection of the treated joint 2 Physical conditions that would eliminate or tend to eliminate adequate implant support or delayed healing viz blood supply limitations poor skin quality previous or active infections sepsis metabolic diseases etc 3 Signs of any local inflammation 4 Patient susceptibility to allergic reaction to the components of the alloy the implant is manufactured from 5 Mental or neurological conditions which tend to pre empt the patients ability or willingness to restrict activities during the healing period viz Parkinsons disease chronic alcoholism Charcots joints drug abuse mental illness patient noncompliance etc 6 Patients having inadequate tissue coverage over the operative site 7 Patient having Foreign body sensitivity 8 Patient with compromised skin 9 Severe osteopenia and or osteoporosis or the presence of marked or rapid bone absorption metabolic bone disease cancer or any other tumor like condition of the bone which may compromise fixation 10 Patient who is pregnant or intends to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Quality of bone union and deformity correction 2 Improvement in ASSH TAF scaleTimepoint: 6 weeks, 3,6, and 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Pain evaluation through VAS 2 Assessment of adverse eventsTimepoint: 6 weeks, 3, 6, and 12 Months | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt Ltd
Outcome results
None listed