Health Condition 1: M999- Biomechanical lesion, unspecified
Conditions
Interventions
Intervention1: VIPLOK Knotless PEEK Anchor with PEEK Tip: VIPLOK Knotless PEEK Anchor with PEEK Tip is intended for soft tissue fixation to the bone, and once implanted will not be removed.
Control In
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/ female participants between =30 years and = 70 of age at the time of consent 2.Participants with Rotator Cuff Tears requiring primary RCT repair 3.Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1.Participants with evidence of osteoarthritis in the shoulder 2.Participants with evidence of infection, tumor or necrosis in the shoulder 3.Participants who had undergone previous surgery of the same shoulder 4.Participants having any contraindications for undergoing MRI 5.Participants with ? 9% HbA1c (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C) 6.Participants with a history of deep vein thrombosis (DVT) 7.Participants who are smokers (smoking ? 20 cigarettes/day) 8.Participants with sensitivity to PEEK/ PLDLA-BTCP material 9.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol. 10.Pregnant and lactating female at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess overall functional outcomes in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-B TCP Anchors with PEEK TipTimepoint: Time frame Screening/ Baseline, month 3, month 6, month 12, month 18 and month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the patient reported outcomes in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip during RCT repair. 2.To assess the failure rate in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip during RCT repair. 3.To assess change in quality-of-life post RCT repair using Sironix all suture anchor in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip 4.To assess recovery period in patients of each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip 5.To assess the duration of surgery. 6.To assess the overall intraoperative handling of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip 7.To assess the incidence of residual risks and safety of Knotless PEEK Anchors with PEEK Tip & Knotless BTCP Anchors with PEEK TipTimepoint: Time frame Screening/ Baseline,Day of surgery, Day 15, month 3, month 6, month 12, month 18 and month 24 | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed