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Clinical Trials/CTRI/2023/06/053602
CTRI/2023/06/053602
Recruiting
Phase 4

A non- randomized, prospective study to evaluate the Safety and Performance of Pelvic Plating System - PMCF-PPS

Auxein Medical Pvt. Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: S329- Fracture of unspecified parts of lumbosacral spine and pelvis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: S329- Fracture of unspecified parts of lumbosacral spine and pelvis
Sponsor
Auxein Medical Pvt. Ltd
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Pms

Investigators

Sponsor
Auxein Medical Pvt. Ltd

Eligibility 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
  • •? Subject diagnosed with fractures, fusions, and osteotomies of
  • •acetabulum, sacrum, ilium and entire pelvic ring
  • •? Subjects need surgery for reconstruction of pelvic and

Exclusion Criteria

  • •? patients with metabolic bone disease.
  • •? patients having inadequate tissue coverage over the operative
  • •? 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

Outcomes

Primary Outcomes

Not specified

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