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