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| Name | Class |
|---|---|
| Arthrex GmbH | INDUSTRY |
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A randomized, double-blind, prospective single-center clinical trial evaluating the effect of biological augmentation in anterior cruciate ligament (ACL) reconstruction. The study compares standard all-inside semitendinosus ACL reconstruction versus biologically enhanced reconstruction incorporating muscle tissue preservation and autologous bone and fibrin augmentation. The primary aim is to assess whether biological augmentation improves graft healing, integration, and clinical outcomes.
Anterior cruciate ligament (ACL) reconstruction outcomes depend on multiple factors including surgical technique, graft selection, fixation methods, and rehabilitation. Hamstring tendon autografts are commonly used due to favorable biomechanical properties and low donor-site morbidity. Traditionally, graft preparation involves complete removal of muscle tissue; however, emerging techniques such as the "candy stripe" method preserve residual muscle, which may provide a source of stem cells and enhance biological healing.
In addition, biological augmentation strategies-including the use of autologous bone graft and platelet-rich fibrin (PRF)-have been proposed to improve tendon-to-bone integration and accelerate ligamentization. These approaches aim to enhance graft incorporation, structural integrity, and overall functional recovery.
This study is a double-blind, randomized, prospective, single-center clinical trial including 70 patients with ACL rupture. Participants are randomly assigned into two groups (n=35 per group):
A control group undergoing standard all-inside ACL reconstruction. An intervention group undergoing biologically augmented ACL reconstruction.
All procedures are performed using an all-inside technique with semitendinosus tendon autografts. The biologically augmented group differs by:
Preservation of a thin layer of muscle tissue on the graft (candy stripe technique) Use of autologous cancellous bone collected during tunnel drilling Application of autologous fibrin glue (platelet-rich fibrin) combined with bone graft to enhance healing at graft-tunnel interfaces The primary objective is to evaluate whether biological augmentation improves graft healing and clinical outcomes compared to standard reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard ACL Reconstruction (Control Group) | Active Comparator | Standard all-inside ACL reconstruction with internal brace augmentation Patients undergo arthroscopic all-inside ACL reconstruction using a quadrupled semitendinosus tendon autograft. The graft is prepared using standard techniques. Fixation is achieved using suspensory fixation devices and internal brace augmentation. No biological augmentation is applied. |
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| Biologically Augmented ACL Reconstruction (Experimental Group) | Active Comparator | Biologically augmented all-inside ACL reconstruction Patients undergo arthroscopic all-inside ACL reconstruction using a semitendinosus tendon autograft with biological augmentation. The procedure includes: Preservation of a thin layer of muscle tissue on the tendon graft (candy stripe technique) Collection of autologous cancellous bone during tunnel drilling Preparation of autologous platelet-rich fibrin (PRF) from peripheral blood Creation of a composite graft using autologous bone mixed with fibrin glue Application of the biological composite material into femoral and tibial sockets to enhance graft integration Fixation is performed using standard suspensory devices consistent with the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL reconstruction | Procedure | Participants will undergo arthroscopic all-inside anterior cruciate ligament reconstruction using an autologous semitendinosus graft. In the experimental intervention, a biologically augmented graft is used, including preservation of muscle tissue on the tendon (candy stripe technique) and application of autologous cancellous bone combined with platelet-rich fibrin at the graft-bone interface. In the control intervention, a standard tendon-only graft is used without biological augmentation. In both groups, graft configuration, tunnel creation, fixation technique, and surgical protocol are identical, and all procedures are performed by the same surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| SNQ | To analyze and compare T2 signal-to-noise ratio values on magnetic resonance imaging at 6 weeks, 6 and 12 months postoperatively within and between the two study groups. The SNQ is calculated as the ratio of the graft T2 signal intensity to the signal intensity of a reference tissue on MRI. Higher SNQ values indicate higher graft signal, which corresponds to lower graft maturity/quality. Scale: Continuous numerical value (exact values depend on MRI signal calibration). | 6 weeks, 6 and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Tunnel Diameter | The diameter of the femoral and tibial bone tunnel measured on MRI at 6 and 12 months postoperatively compared to the intraoperatively drilled diameter. Units: Millimeters (mm) Directionality: Higher values indicate tunnel widening | 6 and 12 months postoperatively |
| Knee Stability - Anterior Tibial Translation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marin Glavčić, MD | Contact | Marin Glavčić , MD +385 1 | mglavcic@kbd.hr |
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The anterior-posterior stability of the operated knee measured with the Lachmeter device at 12 months postoperatively. Units: Millimeters (mm) of anterior tibial translation Directionality: Higher values indicate greater laxity (worse stability) |
| 12 months postoperatively |
| KOOS - Pain Subscale | Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale, assessing knee pain. Scale: 0-100 (0 = extreme pain, 100 = no pain; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Symptoms Subscale | KOOS - Symptoms subscale, assessing knee symptoms (e.g., swelling, stiffness). Scale: 0-100 (0 = severe symptoms, 100 = no symptoms; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Activities of Daily Living (ADL) Subscale | KOOS - ADL subscale, assessing functional ability in daily activities. Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Sports/Recreation Subscale | KOOS - Sports/Recreation subscale, assessing function during sport or recreational activity. Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Quality of Life (QoL) Subscale | KOOS - QoL subscale, assessing knee-related quality of life. Scale: 0-100 (0 = extreme problem, 100 = no problem; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KDC-SKF (International Knee Documentation Committee - Subjective Knee Form) | Patient-reported measure of knee function, symptoms, and sports activity. Scale: 0-100 (0 = worst knee function, 100 = best knee function; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| Rerupture rate | Rates of reruptures of ACL graft in operated patients | 1 year, 2 years and 5 years postoperatively |