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临床试验/NCT03875807
NCT03875807已完成不适用

The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial

Women's College Hospital0 个研究点目标入组 204 人开始时间: 2014年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
204
主要终点
Knee Injury and Osteoarthritis Outcome Score (KOOS)

研究概览

简要总结

The overall aim of this study is to determine the effect of the knee flexion angle (KFA) of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation on postoperative outcomes following single-bundle ACL reconstruction with bone patellar tendon bone (BPTB) autograft. The specific aims of the current study include determining the effect of the knee flexion angle on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.

详细描述

At the present time, there is no consensus about the position of the knee during tensioning anterior cruciate ligament (ACL) graft fixation at the time of reconstruction, although it can be assumed to be one of the key factors for successful ACL reconstruction (ACLR). In studies that have investigated transtibial ACLR, it was suggested that 20 degrees is the ideal KFA to optimize graft force and the relative Antero-Posterior (AP) tibiofemoral relationship, while several other authors have advocated fixation in full extension to avoid overconstraining the knee. In the setting of anatomic ACLR, it has been reported that the tensioning of the graft at 30 degrees of knee flexion was associated with loss of knee extension when the anatomic femoral tunnel was chosen. Previous studies have performed gait analysis during walking in 24 patients with ACLR with hamstring autograft where graft fixation was performed at 25 degrees of knee flexion. In these study, the trans tibial (TT) technique resulted in significantly greater anterior femoral translation than healthy controls during the swing phase and excessive tibial internal rotation (IR) was found at midstance. In knees repaired with the anteromedial portal (AMP) technique, subjects were significantly less extended (5 degrees) compared with controls in late stance phase. While the AMP technique has the potential to improve overall joint stability, patients were shown to have increased difficulty with knee extension. It has also been demonstrated that since the anteromedial (AM) and posterolateral (PL) bundles of the ACL are at their longest in knee extension, the best angle for fixation would be near full extension. The aforementioned studies support the concept that anatomic ACL has an increased likelihood of anisometry and as a result the chosen KFA for fixation becomes increasingly important.

The lack of consensus regarding the optimal KFA in ACLR is reflected in the practice patterns of surgeons. A survey of Canadian Orthopaedic Surgeons demonstrated that 40% of surgeons fix the ACL at a 30 degree KFA while 30% perform fixation in full extension. The purpose of this study is to conduct a randomized controlled trial to determine if the KFA during ACLR graft fixation has an effect on postoperative outcomes. Patients undergoing single bundle BPTB ACLR will be randomized to have the surgical repair done with a KFA of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation. Patients will be followed for 24 months post surgery, with a number of qualitative patient surveys and clinical measurements being collected at 3, 6, 12 and 24 months post op, with changes being compared to baseline survey response and clinical measurement scores.

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, assessors, and data analysts will be blinded in regards to treatment status at all times. Surgeons cannot be blinded given the nature of the intervention. We do not anticipate any circumstance in which unmasking of the data management team, or data analysts will be required, or permissible

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
  • No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
  • Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
  • Surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.
  • Provision of Informed Consent

排除标准

  • Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
  • Associated grade III injury to the MCL (medial opening >10mm at 30 degrees of knee flexion or any medial opening in extension);
  • Presence of a PCL or posterolateral corner injury
  • Lack of informed consent.

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: Completed 24 months post ACL repair at 0 or 30 degrees flexion

The KOOS questionnaire consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

次要结局

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)(Completed 3, 6 and 12 months post ACL repair at 0 or 30 degrees flexion)
  • Marx Activity Score questionnaire(Completed at 3, 6, 12, 24 months post ACL repair at 0 or 30 degrees flexion)
  • Loss of Extension on Operative Knee(Extension is measured at 3, 6, 12 and 24 months post ACL repair)
  • Side to side differences in Anterior Posterior joint stability as measured by the KT-1000 Arthrometer(KT-1000 measurements are recorded at 3, 6,12 and 24 months post ACL repair)
  • Rate of Reoperation(Patients are followed for 24 months post initial ACL surgery to capture any instances of reoperation on the affected knee)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jas Chahal

Orthopaedic Surgeon, Principle Investigator

Women's College Hospital

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