CTRI/2023/04/052027
Recruiting
Phase 4
A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Rotator Cuff Tear Repair Using Knotted UHMWPE Suture Titanium Anchor.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M999- Biomechanical lesion, unspecified
- Sponsor
- Healthium Medtech Limited
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female subjects between 30 to 70 years of age.
- •2\.Subjects with rotator cuff tear requiring primary arthroscopic rotator cuff tear repair surgery.
- •3\.Subject willing to give written informed consent to participate in the study.
Exclusion Criteria
- •1\.Subjects with BMI \=35 kg/m2
- •2\.Subjects with a history of any surgery to the same shoulder.
- •3\.Subjects with active infection or blood supply limitations.
- •4\.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
- •5\.Subjects with known hypersensitivity to titanium or UHMWPE.
- •6\.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
- •7\.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C \= 10\).
- •8\.Subjects with a history of heavy smoking ( \> 20 cigarettes/day) within the last 6 months.
- •9\.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
- •10\.Subjects who are pregnant or lactating at the time of screening
Outcomes
Primary Outcomes
Not specified
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