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A Follow ?up study of variable angle Radius plate intended for wrist fracture fixation.

Phase 4
Conditions
Health Condition 1: Y792- Prosthetic and other implants, materials and accessory orthopedic devices associated with adverse incidents
Registration Number
CTRI/2022/03/041309
Lead Sponsor
Auxein Medical Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other (Terminated)
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1] Patient rated wrist evaluation (PRWE) Score. <br/ ><br>2] Quality of fusion through radio-logical evaluation. <br/ ><br>3] Rate of fracture fixation complicationsTimepoint: Time frame: Baseline, 1,3,6& 12 months post-operatively
Secondary Outcome Measures
NameTimeMethod
1] Grip Strength <br/ ><br>2] Follow-up of the patient recovery through DASH and VAS score <br/ ><br>3] Any implant related complications/adverse events.Timepoint: Time Frame- Pre-operatively (baseline) & 1, 3, 6, 12 months
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