Health Condition 1: M999- Biomechanical lesion, unspecified
Conditions
Interventions
Intervention1: VIPLOK PEEK Knotless anchor with Titanium Tip: VIPLOK PEEK Knotless Anchor is intended for soft tissue fixation to the bone. Once implanted, it will not be removed from the body
Control
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult 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 grade 2 and above in the shoulder as per Samilson and Prieto classification 2.Participants with evidence of infection, osteopenia, tumor or necrosis in the shoulder 3.Participants who had undergone previous surgery of the same shoulder 4.Participants having more than grade 3 fatty infiltration and >50% muscle atrophy 5.Participants with uncontrolled diabetes [HbA1c ? 9% (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C) 6. Participants with known sensitivity to PEEK/ Titanium/ PLDLA-BTCP material 7.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. For ex: Intraoperative diagnosis of severe osteopenia/cyst jeopardizing the stability of the anchor 8.Pregnant and lactating female at the time of screening 9.Participants with known psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess overall functional outcomes in each cohort of knotless PEEK anchors with titanium tip & knotless PLDLA-BTCP anchors with titanium tip.Timepoint: 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 knotless PEEK anchors with titanium tip & knotless PLDLA BTCP anchors with titanium tip. 2.To assess change in quality of life post RCT repair using Sironix all suture anchor in each cohort of knotless PEEK anchors with titanium tip & knotless PLDLA BTCP anchors with titanium tip. 3.To assess the failure rate in each cohort of knotless PEEK anchors with titanium tip & knotless PLDLA BTCP anchors with titanium tip during RCT repair. 4.To assess the overall intraoperative handling of knotless PEEK anchors with titanium tip & knotless PLDLA BTCP anchors with titanium tip. 5.To assess the incidence of residual risks and safety of knotless PEEK anchors with titanium tip & knotless PLDLA BTCP anchors with titanium tip. Timepoint: Time frame Screening or Baseline, 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