Health Condition 1: - Health Condition 2: M999- Biomechanical lesion, unspecified
Conditions
Interventions
Intervention1: Fixed loop UHMWPE suture Titanium button (INFILOOP® Titanium fixed loop button) and Titanium Interference Screw (HELYSIS® Titanium Interference screw): Fixed loop UHMWPE suture Titanium
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects between 18 to 45 years of age. 2.Subjects with ACL injury with or without associated meniscus injuries requiring primary ACL reconstruction surgery. 3.Subject willing to give written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with Posterior Cruciate Ligament injury, and/or Collateral ligament injury. 2.Subjects with known hypersensitivity to titanium and/or UHMWPE suture. 3.Subjects with BMI =35 kg/m2 4.Subjects with a history of previous knee surgery 5.Subjects with the insufficient quantity or skeletally immature bone. 6.Subjects with active infection or blood supply limitations. 7.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation. 8.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period. 9.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C = 10). 10.Subjects with a history of heavy smoking ( > 20 cigarettes/day) within the last 6 months. 11.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study. 12.Subjects who are pregnant or lactating at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the functional outcomes of the knee after ACL Reconstruction surgery from baseline to 24 months post-surgeryTimepoint: Screening, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the condition of the knee (clinical and functional outcome) from baseline to 24 months post-surgery 2. To evaluate the knee stability from baseline to 24 months post-surgery 3. To evaluate the level of activity from baseline to 24 months post-surgery 4. To evaluate the health, symptoms, and functionality of the knee and quality of life from baseline to 24 months post-surgery 5. To evaluate the ACL reconstruction failure rate 6. To evaluate the time to recovery after ACL Reconstruction surgery. 7. To evaluate the overall intraoperative handling of the titanium suture button and titanium interference screw 8. To evaluate the graft and implant condition after ACL Reconstruction surgery 9. To evaluate the adverse events after Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction and safety of titanium suture button and titanium interference screw from baseline to 24 months post-surgeryTimepoint: Screening, day of surgery, Discharge visit, 15 days post surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed