Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Conditions
Interventions
Intervention1: Bioabsorbable Ligament Anchor with fiberwire/tape: 4.5 knotted anchor (loaded with 2 fiber) & 4.75 knotless anchor - Double row repair. 5.5 knotted anchor (loaded with 2 fiber) & 5.5 kn
Sponsors
Chetan Meditech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject with chronic symptomatic rotator cuff tear ( > 6 weeks old) who has failed non-operative treatment. 2. Male or female subject =18 years of age at time of surgery. 3. Subject has provided consent to participate in the study by signing Ethics Committee (EC) approved informed consent form. 4. Subject willing to comply with all the study follow-up procedures and requirements.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the implant material. 2. Patients requiring artificial ligaments to attach in rotator cuff repair. 3. Acute or chronic local or systemic infection. 4. Patients with insufficient or immature bone. 5. Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 6. Pathological conditions of bone & soft tissue, such as cystic changes, tumor or severe osteopenia. 7. Patient conditions including blood supply limitation and previous infections. 8. Comminuted bone surface. 9. Fracture or dislocation of the shoulder joint. 10. Pregnant women. 11. Prior ipsilateral surgeries performed on the joint space. 12. Patients with a medical or physical condition that, in the opinion of Investigator, would preclude safe participation in the study. 13. Participating in another investigational trial or ongoing study that would interfere with the outcomes assessment of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repair failure rate Repair failure rate is defined as the need for reoperation/second repair procedure.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder Range of motion Repair failure rate Simple Shoulder Test questionnaire High Resolution Ultra sonography(HRUS) Radiographic assessment using MRI Pain by Visual Analogue Scale ASES Shoulder Score UCLA Score AE or SAETimepoint: 6, 12, 24 Months | — |
Countries
India
Contacts
Public ContactShweta Patel
Chetan Meditech Pvt. Ltd.
Outcome results
None listed