Health Condition 1: Y792- Prosthetic and other implants, materials and accessory orthopedic devices associated with adverse incidents
Conditions
Interventions
Intervention1: Variable angle Two-column volar distal radius plate: Variable angle Two-column volar distal radius plate used for radial fracture fixation for 24 months
Control Intervention1: NOT APPLI
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ? Subject is willing and able to give written informed consent for participation in the study. ? Male or Female, aged 18 years or above, skeletally mature patient. ? Subject is willing and able to complete equired study visits or assessments. ? Participant has confirmed diagnosis as per the indications
Exclusion criteria
Exclusion criteria: ? Subjects with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc. ? Subject having any neuromuscular disorder, which would create an unacceptable risk of fixation failure or complications in postoperative care. ? Subjects unwilling to sign the Informed Consent document. ? Subjects with substance abuse/alcohol issues. ? Subjects who are incarcerated or have pending incarceration. ? Female participant who is pregnant or planning pregnancy during the course of the study. ? Subject having infection local to the operative site. ? Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study (e.g.,unstable medical status including uncontrolled elevated blood pressure, cardiovascular disease, and glycemic control) or put the subject at risk due to study treatment or procedures. ? Subject with rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. ? Subject having suspected or documented metal allergy or intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1] Patient rated wrist evaluation (PRWE) Score. 2] Quality of fusion through radio-logical evaluation. 3] Rate of fracture fixation complicationsTimepoint: Time frame: Baseline, 1,3,6& 12 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1] Grip Strength 2] Follow-up of the patient recovery through DASH and VAS score 3] Any implant related complications/adverse events.Timepoint: Time Frame- Pre-operatively (baseline) & 1, 3, 6, 12 months | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt. Ltd.
Outcome results
None listed