Performance and safety evaluation of pelvic plate system fixation during fractures, fusions, andosteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint
- Conditions
- Health Condition 1: S329- Fracture of unspecified parts of lumbosacral spine and pelvis
- Registration Number
- CTRI/2023/06/053602
- Lead Sponsor
- Auxein Medical Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
? 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
? 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 ( <1 year) fractures of the pelvis with
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse event (If any)Timepoint: 1, 3, 6, 12 months postoperatively;Change in patient Quality of Life using WHO-BREFTimepoint: 1, 3, 6, 12 months postoperatively;Implant related Complications [Time Frame: baseline, at 1, 3, 6, 12 months <br/ ><br>postoperativelyTimepoint: 1, 3, 6, 12 months postoperatively;Pain on the affected region using Visual Analogue ScaleTimepoint: 1, 3, 6, 12 months postoperatively