Health Condition 1: S629- Unspecified fracture of wrist andhand
Conditions
Interventions
Intervention1: Radius plate system: 12 Months intervention
Control Intervention1: Not applicable: Not applicable
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subject or Subject legal Guardian or Parent willing and able to give informed consent for participation in the study 2 Male or Female aged between 18 to 65 years 3 Participant with confirmed diagnosis as per the indications
Exclusion criteria
Exclusion criteria: 1 Infection local or Systemic Acute or Chronic Inflammation to the operative site 2 Severe osteopenia and or osteoporosis or in 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 Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction the amount of mechanical fixation 3 Insufficient skin tissue bone or neurovascular condition 4 Subjects with high activity levels diabetes high bleeding from vascular Injury 5 Blood circulation problems and blood supply impairment 6 Subject with Suspected or documented metal allergy or in tolerance 7 Psychologically or physiologically inadequate subjects 8 Severe bow or gross distortion of the radius 9 Female participant who is pregnant or planning pregnancy during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Quality of bone union 2 PRWE to measure wrist pain 3 Evaluation of hand grip strengthTimepoint: 6 weeks, 3, 6 and 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain evaluation through Visual Analogue Score Timepoint: 6 week 3 month 6 month 12 month;Assessment of complicationsTimepoint: 6 week 3 month 6 month 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed