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Clinical Trials/CTRI/2022/03/041309
CTRI/2022/03/041309
Other
Phase 4

A Non ?Randomized, prospective Post Market Clinical Follow ?up study to evaluate theSafety and Performance of Radius system intended for Radius fracture fixation.

Auxein Medical Pvt Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: Y792- Prosthetic and other implants, materials and accessory orthopedic devices associated with adverse incidents

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: Y792- Prosthetic and other implants, materials and accessory orthopedic devices associated with adverse incidents
Sponsor
Auxein Medical Pvt Ltd
Status
Other
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 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

  • •? 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

Outcomes

Primary Outcomes

Not specified

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