ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
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- STATUS
- Recruiting
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- End date
- Dec 1, 2023
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- participants needed
- 112
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- sponsor
- Vita Care
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.
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
Details
| Condition | Trauma, Wounds, KNEE INJURY, Knee Injuries, sports injury, Athletic Injuries, Anterior Cruciate Ligament Tear, Rupture of Anterior Cruciate Ligament, Knee Trauma, ACL Injury, Anterior Cruciate Ligament Injury, ACL Tear, Wounds, Athletic Injuries, Knee Injuries, acl injuries |
|---|---|
| Treatment | Surgical technique combined with a specific choice of the material for the ligament reconstruction |
| Clinical Study Identifier | NCT04550299 |
| Sponsor | Vita Care |
| Last Modified on | 25 January 2021 |
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