Health Condition 1: M799- Soft tissue disorder, unspecified
Conditions
Interventions
Intervention1: T-Button A PEEK Adjustable Loop Button: The T-Button A PEEK Adjustable Loop Button is a permanently implantable Polyether Ether Ketone (PEEK) cortical tibial suspension fixation devic
Sponsors
Dr. Rudra Prasad M S
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with traumatic ACL tears with or without associated meniscus injuries requiring primary ACL reconstruction surgery 2. 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 greater than or equal to 35 kg/m2 3. Participants who had undergone previous surgery in the same or contralateral knee 4. Participants with a history of deep vein thrombosis (DVT) 5. Participants with arthritis of same or contralateral knee 6. 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 7. Pregnant and lactating female at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess functional outcomes of Knee post-surgery within the groups and between the two groups.Timepoint: Screening/ Baseline, month 1.5, month 3, month 6, and month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the clinical symptoms and activity level between the two groups. 2. To assess the failure rate of ACL reconstruction between the two groups. 3. To assess change in quality of life in patients between the two groups. 4. To assess the duration of surgery between the two groups 5. To assess the overall intraoperative handling between the two groups. 6. To assess the safety of the implantsTimepoint: 1. Screening/ Baseline, month 1.5, month 3, month 6 and month 12 2. All visits after surgery including surgery day 3. Screening/ Baseline, month 12 6. All visits after surgery including surgery day | — |
Countries
India
Contacts
Public ContactDr Rudra Prasad M S
SPARSH Super Specialty Hospital
Outcome results
None listed