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临床试验/NCT04123834
NCT04123834已完成1 期

Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autografts Using Press-Fit Fixation Technique and Hamstring Autografts Using Implant in Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective Study

Indonesia University0 个研究点目标入组 32 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
32
主要终点
Functional outcome score Tegner-Lysholm

研究概览

简要总结

The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.

详细描述

Purpose: The use of implants for conventional anterior cruciate ligament (ACL) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. Implantless ACL surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. The investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.

Materials and Methods

A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • total rupture of ACL on a single knee

排除标准

  • increased knee laxity according to Beighton Hypermobility Score
  • previous history of knee surgery

研究组 & 干预措施

implantless Arthroscopic ACL reconstruction

Experimental

implantless Arthroscopic ACL reconstruction using press-fit femoral technique

干预措施: Patella tendon & bone block autograft + press-fit femoral technique (Procedure)

implantless Arthroscopic ACL reconstruction

Experimental

implantless Arthroscopic ACL reconstruction using press-fit femoral technique

干预措施: Arthroscopic ACL reconstruction (Procedure)

Arthroscopic ACL reconstruction with implant

Experimental

ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)

干预措施: Arthroscopic ACL reconstruction (Procedure)

Arthroscopic ACL reconstruction with implant

Experimental

ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)

干预措施: Hamstring tendon autograft + implant fixation (Device)

结局指标

主要结局

Functional outcome score Tegner-Lysholm

时间窗: At 1 month after surgery.

Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life. Number of items: 8 items, each scored differently Subscales: 1. limp (0, 3, 5) 2. support (0, 2, 5) 3. locking (0, 2, 6, 10, 15) 4. instability (0, 5, 10, 15, 20, 25) 5. pain (0, 5, 10, 15, 20, 25) 6. swelling (0, 2, 6, 10) 7. stair climbing (0, 2, 6, 10) 8. squatting (0, 2, 4, 5) Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.

Anterior knee laxity

时间窗: At 6 months after surgery.

Anterior knee laxity (in centimetres) was assessed by measuring anterior translation at 30° of flexion with a rolimeter and comparing it with the contralateral knee.

Functional outcome scores Tegner-Lysholm

时间窗: At 6 months after surgery.

Tegner-Lysholm Score subjectively evaluate to how the knee pain has affected the ability to manage in everyday life. Number of items: 8 items, each scored differently Subscales: 1. limp (0, 3, 5) 2. support (0, 2, 5) 3. locking (0, 2, 6, 10, 15) 4. instability (0, 5, 10, 15, 20, 25) 5. pain (0, 5, 10, 15, 20, 25) 6. swelling (0, 2, 6, 10) 7. stair climbing (0, 2, 6, 10) 8. squatting (0, 2, 4, 5) Total score is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points.

Functional outcome score International Knee Documentation committee (IKDC)

时间窗: At 6 months after surgery.

International Knee Documentation committee (IKDC) score evaluate improvement or deterioration in symptoms, function, and sports activities. Number of items: 18 subscales: * symptoms: pain, stiffness, swelling, locking/catching and giving-way of the knee. * sports activities: functions such as going up and down the stairs, rising from a chair, squatting and jumping * function and activity of daily living: knee condition prior to injury Response options vary for each item. Item 6 dichotomizes response into yes/no; items 1, 4, 5, 7, 8, and 9 use 5-point Likert scales; and items 2, 3, and 10 use 11-point numerical rating scales. The total score is calculated as (sum of items)/(maximum possible score) × 100. Possible score range 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. Higher values represent a better outcome.

Functional outcome score Knee Injury and Osteoarthritis Outcome (KOOS)

时间窗: At 6 months after surgery.

Knee Injury and Osteoarthritis Outcome (KOOS) measure patients' opinions about their knee and associated problems over short- and long-term followup (1 week to decades). Number of items: 42 items rated on a 5-point Likert scale (0-4) across 5 subscales: * pain frequency and severity during functional activities (subscale score range: 0-36) * symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction (subscale score range: 0-28) * difficulty experienced during activities of daily living (ADL) (subscale score range: 0-68) * difficulty experienced with sport and recreational activities (subscale score range: 0-20) * knee-related quality of life (QOL) (subscale score range: 0-16) The 5 dimensions are scored separately as the sum of all corresponding items, and then converted into percentage (score range 0-100). Score of 0 means extreme knee problems and score of 100 means no knee problems.

次要结局

未报告次要终点

研究者

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

Andri Maruli Tua Lubis

Principal Investigator

Indonesia University

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