The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Tendon-Bone Healing Assessed by MRI Grading System
研究概览
简要总结
- Comparison of the grafts using Magnetic Resonance Imaging (MR) to determine whether their maturation and bone integration are different,
- Comparison of the grafts using Computerized Tomography (CT) to determine whether their effects on the tunnels opened in cruciate ligament reconstruction surgeries are different,
- In the event that graft healing and effects on the tunnels differ between grafts, determination of whether these differences are related to patient clinics,
详细描述
The project method; Patients who will be operated with 2 different grafts used in anterior cruciate ligament surgeries will be included in 2 different randomized groups of 29 people (hamstring and peroneus groups) determined by obtaining their informed consent before the surgery and then,
- The maturation of the grafts will be measured and compared with the SNQ (Signal/Noise quotient) value and the graft-bone integration with the measuring Tendon Bone Healing Grade with the Magnetic Resonance (MR) to be taken at the 1st year controls after the surgery,
- Changes in tunnel morphology; The volume of the tunnels will be measured with the Computerized Tomography (CT) imaging method to be taken prospectively within the first week after the surgery date and 1 year after the surgery date and the changes within 1 year will be calculated by comparing them.
- In the outpatient clinic follow-ups of both groups; Knee laxity will be obtained with Lachman, Anterior drawer and Pivot shift tests and knee scores and activity levels will be obtained using IKDC, Lysholm, Marx activity scales and it will be examined whether these data are related to SNQ, Tendon Bone Healing Grade and tunnel expansion.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the surgical interventions, blinding of participants and surgeons was not feasible. However, outcome assessors were blinded to group allocation using anonymized imaging data.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 45 years.
- •BMI in the range of 18 to
- •Diagnosed with an anterior cruciate ligament (ACL) injury preoperatively confirmed by MRI.
- •Patients for whom it is deemed appropriate to harvest ipsilateral hamstring tendons or Peroneus Longus tendon for use as a graft.
排除标准
- •History of previous surgery on the affected knee or ankle.
- •Presence of multiple ligament injuries in the affected knee.
- •ACL injuries that occurred more than 12 months prior to surgery.
- •Evidence of unstable meniscal injury on preoperative MRI that may alter the -postoperative rehabilitation protocol.
- •Inability to obtain a graft diameter of at least 9 mm using the isolated graft.
- •Presence of meniscal tears requiring repair.
- •Presence of advanced chondral lesions requiring surgical intervention.
- •Intraoperative detection of multiple ligament injuries.
- •Requirement for additional surgical procedures that would alter the standard rehabilitation protocol.
- •Occurrence of intraoperative surgical complications.
研究组 & 干预措施
Peroneus Longus Group
Participants who underwent ACL reconstruction using Peroneus Longus tendon graft.
干预措施: Surgical procedure using Peroneus Longus for ACL reconstruction. (Procedure)
Hamstring Group
Participants who underwent ACL reconstruction using Hamstring tendon graft.
干预措施: Surgical procedure using Hamstring tendons for ACL reconstruction. (Procedure)
结局指标
主要结局
Tendon-Bone Healing Assessed by MRI Grading System
时间窗: 1 year postoperatively.
Comparison of graft-bone integration between peroneus longus and hamstring tendon autografts using MRI Grading System obtained from 1-year postoperative MRI.
Graft Maturation Assessed by Signal-to-Noise Quotient (SNQ) on MRI
时间窗: 1 year postoperatively.
Comparison of graft maturation between peroneus longus and hamstring tendon autografts using SNQ values obtained from 1-year postoperative MRI.
Change in Tunnel Volume Assessed by CT
时间窗: Within 1 week post-surgery and at 1 year post-surgery.
Comparison of tunnel volume changes between peroneus longus and hamstring tendon autografts by measuring tunnel volume via CT imaging performed within the first week and 1 year after surgery.
次要结局
- Patient-Reported Knee Function and Activity Levels(At 1-year follow-up.)
- Comparison of Graft Healing and Tunnel Changes Between Groups(1 year postoperatively.)
- Knee Laxity Assessed by Clinical Tests(At 1-year follow-up.)
- Relationship Between Tunnel Changes and Clinical Outcomes(At 1-year follow-up.)
研究者
Fevzi Gurkan Aslan
Dr
Karadeniz Technical University