Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Interference screw with PEEK material (HELYSIS®: PEEK Interference Screw): Interference screw with PEEK material (HELYSIS®: PEEK Interference Screw) is used for fixation of tissue, incl
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/ female participants between =18 years and = 45 years of age at the time of consent 2.Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery 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 lateral/medial collateral ligament injury or posterior cruciate ligament injury 2.Participants with BMI =35 kg/m2 3.Participants who had undergone previous surgery in the same or contralateral knee 4.Participants with HbA1c ? 9% (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C) 5.Participants who are smokers (smoking ?20 cigarettes/day) 6.Participants with sensitivity to PEEK/PLDLA/B-TCP material 7.Participants with a history of deep vein thrombosis (DVT) 8.Participants with arthritis of same or contralateral knee 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 clinical investigation plan 10.Pregnant and lactating female at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess functional outcomes of Knee in each cohort of Interference screw with PEEK material and PLDLA-BTCP material.Timepoint: Screening, month 3, month 6,month 12, month 18 and month24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the clinical symptoms and activity level in each cohort of Interference screw with PEEK material and PLDLA-BTCP material. 2.To assess the failure rate of ACL reconstruction in each cohort of Interference screw with PEEK material and PLDLA-BTCP material. 3.To assess change in quality of life in patients of each cohort of Interference screw with PEEK material and PLDLA-BTCP material. 4.To assess recovery period in patients of each cohort of Interference screw with PEEK material and PLDLA-BTCP material. 5.To assess the duration of surgery. 6.To assess clinical condition of the knee. 7.To assess the overall intraoperative handling of Interference screw with PEEK material and PLDLA-BTCP material. 8.To assess the incidence of residual risks and safety of Interference screws with PEEK material and PLDLA-BTCP material. Timepoint: Screening, Day of surgery, Discharge visit, 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