Health Condition 1: M999- Biomechanical lesion, unspecified
Conditions
Interventions
Intervention1: CEPTRE Knotted UHMWPE Suture PEEK Anchor: CEPTRE Knotted UHMWPE Suture PEEK Anchor is intended for soft tissue fixation to the bone. It will be a permanent implant and will not be remov
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 HbA1c ? 9%. (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 Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP AnchorTimepoint: Time frame Screening or 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 Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor during RCT repair 2.To assess the failure rate in each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor during RCT repair 3.To assess change in quality-of-life post RCT repair using Sironix all suture anchor in each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor 4.To assess recovery period in patients of each cohort of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor 5.To assess the duration of surgery 6.To assess the overall intraoperative handling of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor 7.To assess the incidence of residual risks and safety of Knotted UHMWPE Suture PEEK Anchor and Knotted UHMWPE Suture PLDLA and B TCP Anchor Timepoint: Time frame Screening or 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