Health Condition 1: M999- Biomechanical lesion, unspecified
Conditions
Interventions
Intervention1: CEPTRE Knotted UHMWPE Suture Titanium Anchor: CEPTRE Knotted UHMWPE Suture Titanium Anchor is intended for soft tissue fixation to the bone. It will be a permanent implant and will not
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the functional outcomes of the shoulder after Arthroscopic Rotator Cuff Tears Repair from baseline to 24 months post-surgery.Timepoint: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the condition of the shoulder (clinical and functional outcome) from baseline to 24 months post-surgery. 2.To evaluate the quality of life from baseline to 24 months post-surgery. 3.To evaluate the shoulder pain and function from baseline to 24 months post-surgery. 4.To evaluate the Arthroscopic Rotator Cuff Tears repair failure rate. 5.To evaluate the time to recovery after Arthroscopic Rotator Cuff Tears repair surgery. 6.To evaluate the overall intraoperative handling of the Knotted UHMWPE Suture Titanium Anchor. 7.To evaluate the rotator cuff and implant condition after Arthroscopic Rotator Cuff Tears repair surgery. 8.To evaluate the adverse events after Arthroscopic Rotator Cuff Tears Repair and safety of the Knotted UHMWPE Suture Titanium Anchor from baseline to 24 months post-surgery. Timepoint: Day of surgery, Day of Discharge, 15th day post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed