ACL Injury, ACL Tear, Knee Injuries, Sports Injury
Conditions
Brief summary
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.
Detailed description
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports. This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant. Primary outcome is graft ligamentization assessed in MRI images at 4-6 months
Interventions
OTHERSurgical technique combined with a specific choice of the material for the ligament reconstruction
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Sponsors
Johnson & Johnson
Vita Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)
Exclusion criteria
intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone-graft integration | 4-6 months | Bone-graft integration assessed in the MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical scores | 4-12 months | Knee laxity (KT1000, 0 to 5 mm range, higher scores = worse outcome), Objective and Subjective International Knee Documentation Committee (Objective IKDC: 0-100 range, higher scores = better outcomes; Subjective IKDC: A-D range; A = better outcomes) scores, Lysholm score (0-100 range, higher scores = better outcomes) and Tegner Activity Scale (0-10 range, higher scores = higher levels of physical activity/ competitive sport activity) |
| Retear | Through study completion, an average of 2 years | Retear of the reconstructed ACL |
Countries
Brazil
Contacts
Primary ContactInstituto Vita
Backup ContactWagner Castropil
Outcome results
None listed