A Double-blind, Randomized, Prospective, Single-center Study of Biological Potentials in Arthroscopic All-inside Semitendinosus Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- SNQ
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and radiologically confirmed anterior cruciate ligament (ACL) rupture.
- •Age between 18 and 50 years.
- •Intact posterior cruciate ligament and collateral ligaments.
- •Signed informed consent to participate in the study.
- •Patients meeting at least one indication for concomitant lateral tenodesis, including: age under 25 years, positive pivot-shift test, presence of Segond fracture, participation in sports with frequent changes of direction and rotational knee loads, or joint hypermobility (Beighton score ≥ 7).
排除标准
- •Previous ACL reconstruction of the same knee.
- •Inability to use a graft prepared by quadruple folding of the semitendinosus tendon.
- •Graft diameter < 7.5 mm.
- •MRI-confirmed unsuccessful meniscal healing after repair.
- •Acute joint infection or history of joint infection.
研究组 & 干预措施
Standard ACL Reconstruction (Control Group)
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.
干预措施: ACL reconstruction (Procedure)
Biologically Augmented ACL Reconstruction (Experimental Group)
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.
干预措施: ACL reconstruction (Procedure)
结局指标
主要结局
SNQ
时间窗: 6 weeks, 6 and 12 months postoperatively
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).
次要结局
- Bone Tunnel Diameter(6 and 12 months postoperatively)
- Knee Stability - Anterior Tibial Translation(12 months postoperatively)
- KOOS - Pain Subscale(Before surgery, 6 weeks, 6 months, 12 months postoperatively)
- KOOS - Symptoms Subscale(Before surgery, 6 weeks, 6 months, 12 months postoperatively)
- KOOS - Activities of Daily Living (ADL) Subscale(Before surgery, 6 weeks, 6 months, 12 months postoperatively)
- KOOS - Sports/Recreation Subscale(Before surgery, 6 weeks, 6 months, 12 months postoperatively)
- KOOS - Quality of Life (QoL) Subscale(Before surgery, 6 weeks, 6 months, 12 months postoperatively)
- KDC-SKF (International Knee Documentation Committee - Subjective Knee Form)(Before surgery, 6 weeks, 6 months, 12 months postoperatively)
- Rerupture rate(1 year, 2 years and 5 years postoperatively)
研究者
Marin Glavčić
Principal Investigator
University Hospital Dubrava