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临床试验/NCT03505359
NCT03505359Unknown不适用

Post-operative Rehabilitation Protocol for Combined Reconstruction of Anterior Cruciate Ligament and Anterolateral Knee Ligament Surgery

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
28
试验地点
1
主要终点
Knee Function

研究概览

简要总结

Introduction: Individuals with an ACL lesion present abnormal rotational stability. Among the structures located in the anterolateral region of the knee that could act as restraints of the rotational knee lassitude, there is the Anterior Lateral Ligament (ALL), and its reconstruction associated with ACL reconstruction could reduce recurrence injury rates. Objective: to develop a rehabilitation protocol for patients undergoing combined reconstruction of ACL and ALL. METHOD: Articles published with patients submitted to ACL reconstruction with an anatomic technique and flexor tendon graft, (which is the same one adopted in this study), were selected as a base to this protocol. Discussion: The results will provide important information on clinical practice, since it can help identify the necessity or not of restraining the knee range of motion in combined surgeries. It can guide the therapeutic planning, including the cost of knee restraint devices, in addition to estimating these patients prognosis. The protocol with partial restriction of knee range of motion in the first 6 weeks of postoperative is the most indicated program in the rehabilitation of the combined surgeries of ACL and ALL reconstruction.

详细描述

Currently, the anatomical reconstruction of the ACL has been widely used, with the purpose of increasing the knee rotational control after the injury, and thus, to improve the clinical evolution in the long term. The concept involves restoring knee kinematics by improving function by reducing the number of graft failures, delaying or preventing degeneration of the joint. Normally, rehabilitation protocols in these cases are more careful with respect to knee ROM gain and use of exercises in open kinetic chain, with the purpose of preserving the graft.

Allied to this concept, the use of extra-articular reconstruction associated with ACL reconstruction, gained new horizons with the discovery of ALL, signaling to the possibility of a better rotational control and, consequently, a decrease in the number of graft failures.

Due to the particularities of each surgical technique, it is necessary that the rehabilitation protocols adapt to the different methods, guaranteeing the functional recovery, but without damages to the reconstruction.

With the proposal of ACL reconstruction surgery associated with ALL reconstruction, it is necessary to develop a specific rehabilitation protocol for these patients, considering some postoperative specificities of extra-articular reconstructions, since they are data that are not available in the literature until now.

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 (Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Aged from 18 to 40 years
  • •Documented and symptomatic anterior cruciate ligament (ACL) injury followed by ACL+ anterolateral ligament (ALL) ligament reconstruction

排除标准

  • •Patients with multiple ligament injuries
  • •Bilateral ACL injury

研究组 & 干预措施

Experimental group

Experimental

Group treated by the new protocol with partial knee immobilization

干预措施: partial knee immobilization protocol (Other)

Control group

Active Comparator

Group treated by a standard protocol for ACL reconstruction.

干预措施: standard ACL reconstruction rehabilitation protocol (Other)

结局指标

主要结局

Knee Function

时间窗: 12 months

Lysholm Knee Scoring Scale: instrument consisting of eight domains: limping, support, re-straining, instability, pain, swelling, climbing stairs and squatting, with closed-answers alternatives. The final result is expressed in nominal and ordinal form, being "excellent" ranging from 95 to 100 points; "Good" from 84 to 94 points; "Regular" between 65 and 83 and "bad" when values are equal to or less than 64.

次要结局

  • Static Postural Control(3 weeks; 6 weeks; 12 weeks; 6 months and 12 months)
  • Muscle strength(3 weeks; 6 weeks; 12 weeks; 6 months and 12 months)
  • Dynamic Postural Control(3 weeks; 6 weeks; 12 weeks; 6 months and 12 months)
  • Follow-up of knee function(3 weeks; 6 weeks; 12 weeks; 6 months)

研究者

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

Silvia Maria Amado João

Principal Investigator

University of Sao Paulo General Hospital

研究点 (1)

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