Health Condition 1: S329- Fracture of unspecified parts of lumbosacral spine and pelvis
Conditions
Interventions
Intervention1: Auxein Medicle Pelvic Plating System: ? Intended to provide fixation during fractures, fusions, and
osteotomies of the acetabulum, sacrum, ilium, and entire pelvic
ring, as well as tre
Sponsors
Auxein Medical Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ? Subject is willing and able to give informed consent for participation in the study. ? male and female above 18 years to 70 year skeletally mature patients. ? Subject diagnosed with fractures, fusions, and osteotomies of acetabulum, sacrum, ilium and entire pelvic ring ? Subjects need surgery for reconstruction of pelvic and acetabulum
Exclusion criteria
Exclusion criteria: ? patients with metabolic bone disease. ? patients having inadequate tissue coverage over the operative site. ? patients with skeletal immaturity. Systemic bone disease, neurological injuries of the lumbosacral plexus and urological injuries. ? Patients that have compromised vascularity that would inhibits adequate blood supply to the fracture or the operative site. ? Suspected or documented allergy or intolerance to implant materials. Surgeon shall find out if the patient develops an allergic reaction to the material of the implant (content of the implant material is presented in IMPLANT MATERIAL). ? severe lower back pain due to other causes such as lumbar disc degeneration ,Lumbar disc herniation lumbar spondylolisthesis, spinal stenosis , lumbar facet degeneration. ? Spine surgery during the past 12 months ? History of recent ( documented malunion , non union of sacrum, illium or any type of internal fixation of the pelvic ring. ? Previously diagnosed or suspected osteoporosis. ? any condition or anatomy that makes treatment with the pelvic plate system infeasible. ? Prominent neurological condition that would interfere with physical therapy. ? Diagnosed psychiatric disease (E.g Schizophrenia, Major depression, personality disorder) that would interfere with study participation. ? pregnant women or planning pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing [Time Frame: baseline, 1, 3, 6, 12 months after surgery] evaluated by X-ray images.Timepoint: 1, 3, 6, 12 months postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Implant related Complications [Time Frame: baseline, at 1, 3, 6, 12 months postoperativelyTimepoint: 1, 3, 6, 12 months postoperatively;Pain on the affected region using Visual Analogue ScaleTimepoint: 1, 3, 6, 12 months postoperatively;Change in patient Quality of Life using WHO-BREFTimepoint: 1, 3, 6, 12 months postoperatively;Adverse event (If any)Timepoint: 1, 3, 6, 12 months postoperatively | — |
Countries
India
Contacts
Public ContactGaurav Luthra
Maulana Azad Medical College & Associated Lok Nayak Hospital
Outcome results
None listed