A Single-center, Patient-blinded, Randomized, 2-year, Parallel-group, Superiority Study to Compare the Efficacy of Augmented ACL Integration Via Platelet-rich-plasma Enriched Collected Autologous Bone Versus Standard ACL Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Tibial tunnel diameter change
研究概览
简要总结
The purpose of this clinical study is to compare the outcomes of two surgical techniques for reconstruction of the anterior cruciate ligament (ACL) after a single, primary ACL rupture.
The main question to be answered is:
- Does less widening of the tibial tunnel occur when a bone/Platelet rich plasma (PrP) composite material is placed directly into the tibial tunnel after fixation of the implant (experimental group) compared to the same surgery without the use of the composite material (control group)?
Participants will be randomized into one of the two groups and they will not know which group they belong to. After 12 months they will undergo CT, MRI, medical examination and functional knee testing. They will have a further medical examination and functional knee testing at 24 months. Patient Reported Outcomes will be collected before surgery, 6, 12 and 24 months after surgery.
详细描述
To be successful, an ACL reconstruction requires a strong incorporation of the tendon to the bone within or at the margin of the tunnel, but the tunnel itself is at risk of widening, therefore compromising the tendon attachment. A composite of harvested healthy autologous bone fragments from the tunnel and autologous thrombin and fibrin, generated from the patient's PrP could be used at the interface between tunnel and ACL graft at the tibia and femur to reduce frequency of tunnel widening and therefore improve graft-bone-integration.
The study seeks primarily to determine less tibial tunnel widening when a bone/PrP-composite is applied directly in the tibial tunnel compared to the same surgery without using the composite, measured with CT and MRI.
Secondary study objectives are to evaluate femoral tunnel widening, tibial and femoral graft incorporation, graft maturation and knee function (clinical, functional, patient reported) over the course of 24 months follow-up and to evaluate occurrence of procedure- and product-related adverse events and complications.
This is a prospective, single-center, single-blinded, 2-arm-parallel, randomized, controlled study with 24 months follow-up. Participants will be recruited from the Knee Surgery department at Schulthess Klinik when scheduled for ACL reconstruction. The study sample comprises 107 patients, allocated 1:1 on experimental and control arm. Outcome measures are taken at 0, 6, 12, and 24 months. The total study duration is 48 months. The study duration per patient is 24 months.
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)
盲法说明
Patients are blinded. As well, staff conducting and evaluating MRI, clinical evaluation, CT and functional tests are blinded.
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
- •Age 18-50 years
- •Primary ACL rupture
- •Time from injury to surgery: 4 weeks to 6 months
- •Single ACL rupture (isolated rupture)
- •ACL surgery with one of the participating senior surgeons
- •Informed Consent as documented by signature
排除标准
- •Concomitant ligamentous instability/rupture
- •Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)
- •Requirement for cartilage invasive treatment (debridement accepted)
- •Osteoarthritis at index knee joint
- •Leg axis deviation over 3° valgus or 4° varus
- •Claustrophobia (contra-indication for the MRI)
- •Women who are pregnant or breast feeding or intention to become pregnant during the study
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.
结局指标
主要结局
Tibial tunnel diameter change
时间窗: 10 to 14 months post-surgery
Diameter (mm) change of tibial tunnel in relation to tunnel diameter reported from surgery; assessed by one radiologist (CT); CT scanning is performed from a level just above the femoral external foramen to a level below the outer hole of the tibial tunnel in order to visualise the positioning of the autograft-fixing metallic devices. The scan is aligned so that the tunnel axis is in the sagittal plane. The diameter of the headed reamer that drilled the tibial tunnel is defined as the baseline diameter of the tibial tunnel (D0). Measurements are taken at 4 different levels for the tibial tunnels using 3D Multiplanar reconstruction. All diameters are calculated in mm within the measurement function of the picture archiving system. The percentage of widening is defined as the difference between initial drilling diameter D0 (derived from surgery report) and post-op measurements D12 in relation to initial drilling diameter D0.
Tibial tunnel volume change
时间窗: 10 to 14 months post-surgery
Volume (mm\^3) change of tibial tunnel in relation to tunnel volume reported from surgery; assessed by one radiologist (CT); the border of the bone tunnel is drawn manually on every fourth slice in both the coronal plane and the sagittal plane and interpolated automatically in between. Based on the contours in those two planes, the contours in the axial plane are interpolated automatically into a 3D mask. The volume of the bone tunnel is determined by automatic voxel counting\^.
次要结局
- Femoral tunnel diameter change(10 to 14 months post-surgery)
- Graft maturity_subj(10 to 14 months post-surgery)
- Graft integration(10 to 14 months post-surgery)
- Femoral tunnel volume change(10 to 14 months post-surgery)
- Graft maturity_obj(10 to 14 months post-surgery)
- Bone healing and integration(10 to 14 months post-surgery)