Study of shoulder joint treatment
- Conditions
- Health Condition 1: S460- Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder
- Registration Number
- CTRI/2024/07/069812
- 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 Written informed consent for participation.
? No history of surgery on affected Shoulder.
? Male or Female, aged between 18 to 75 years.
? Subject scheduled for Shoulder arthroscopic surgery for fixation of Shoulder related
ligaments and tendons repair.
? Subject having any local active infections, blood supply limitations, diseases or other
systemic conditions that may retard healing or create unacceptable risk of fixation failure.
? Subject having inadequate tissue coverage on the operative site, where suture anchor
performances would be compromised.
? Subject having foreign body sensitivities where precautionary or mitigation methods are
inadequate to control the conditions.
? Subjects with substance abuse/alcohol issues.
? Subjects who are incarcerated or have pending incarceration.
? Subjects with mental disorders
? Subject who has contraindication mentioned in the IFU.
? Female participant who is pregnant or planning pregnancy during the course of the clinical
study.
? Subjects inability or unwillingness to follow surgeon’s prescribed post-operative care after
shoulder arthroscopy surgery.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Time taken to achieve full weight lifting capacity. <br/ ><br>2. Evaluation of functional scores; ASES and WOSI following the <br/ ><br>arthroscopic surgery.Timepoint: 6 weeks, 3, 6, 12 months
- Secondary Outcome Measures
Name Time Method 1. Evaluation of shoulder pain by VAS following arthroscopic surgery. <br/ ><br>2. Assessment of device related of AE, and SAEs.Timepoint: 6 weeks, 3, 6, 12 months