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临床试验/NCT02816606
NCT02816606Unknown不适用

Radiological Follow-up of Alternative ACL Reconstruction Technique

Royal Devon and Exeter NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Anterior Cruciate Ligament Reconstruction Integrity

研究概览

简要总结

Following recent advances in the understanding of successful anterior cruciate ligament (ACL) reconstruction, three important factors have been identified: femoral tunnel positioning, femoral tunnel aperture shape, and native remnant preservation. Accordingly, the researchers have adapted their technique to address these goals. This study is designed to assess the feasibility of evaluating these graft characteristics, on post-operative imaging, and the ability to show potential improvements with the researchers' technical changes. The study plans to use three-dimensional computer tomography (3D-CT) and magnetic resonance imaging (MRI) to assess these properties and the integration of the graft. In addition, the researchers will use their routine functional scores to monitor the patients' outcome. If successful, the research team hope to set-up a randomised control trial of this alternative technique versus conventional methods with assessment through the same imaging mediums and clinical follow-up.

详细描述

Rupture of the ACL has an incidence of 30 cases per 100,000 individuals in the UK. The number of reconstructions performed is increasing as more patients wish to maintain optimum knee function and stability, in older age-groups, than previously seen. The research centre (hospital) presently performs between 100 and 150 ACL reconstructions each year but, thus, this figure is likely to continue to rise.

The ACL performs a role in preventing anterior translation of the tibia on the femur, throughout the range of motion of the knee, but also provides rotational stability. Inadequate post-injury function, or failure, can result in continued feeling of instability (within the knee) and this may prevent return to employment as well as recreational activities. This is of particular importance to heavy manual workers and competitors in change-of-direction sports.

Reconstruction of the ACL most commonly involves the use of autologous hamstring or patellar tendon grafts that are implanted during an arthroscopic procedure. Rehabilitation, following reconstruction, is lengthy as the graft takes months to incorporate and over a year to regain mechanical properties. Therefore, these patients undergo a long period of functional rehabilitation, under the guidance of the physiotherapists, with repeated outpatient surgical follow-up to assess recovery and detect rare (but important) complications of surgery.

As understanding of the anatomy and biomechanics of the ACL has improved, the techniques used to perform this procedure have evolved accordingly. The goals of reconstructive surgery are to restore stability to the knee and allow the patient to return to employment and recreational activities. Research over the last 5 years has increasingly turned to defining the anatomy of this ligament and positioning the graft in an anatomical position. Bony landmarks have been identified for the position of the femoral footprint of the ACL - the intercondylar and bifurcate ridges - making positioning of the graft accurately possible. Appreciation of the importance of the remnant tissue - as an indication of previous attachment and as a conduit for revascularisation of the graft - and these bony landmarks for the tibial and femoral attachments, of the ligament, have led to changes in surgical philosophy and technique.

Of particular interest is the femoral tunnel. Successful ACL reconstruction has clearly been shown to be associated with femoral tunnel positioning so that the graft is centred in the original footprint and replicates the normal biomechanics of the knee. As there is a degree of variation between individuals, previous methods of positioning the graft relative to other structures (or using surrogate measurements) have been superseded by the need to identify these remaining anatomical landmarks. Therefore, operative technique has focussed on femoral footprint identification and centring the graft within this area.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients (Aged 18-50) undergoing ACL reconstruction in our unit

排除标准

  • Age under 18 years
  • Patient refusal following informed consent process
  • Inability to undergo post-operative imaging (non-attendance, metal in body preventing MRI, pregnancy preventing CT)
  • Different reconstruction technique chosen for clinical reasons.
  • Revision procedures
  • Previous surgery to the knee (or injury) that may affect the anatomy defined.

结局指标

主要结局

Anterior Cruciate Ligament Reconstruction Integrity

时间窗: 12 months post-operative

Assessed clinically and using MRI at 12 months post-operative

次要结局

  • Reamer size used for tibial and femoral tunnels(Intraoperative)
  • Length of femoral tunnel(Intraoperative)
  • Width of femoral tunnel(Intraoperative)
  • Presence of Tibial Stump(Intraoperative)
  • Dimensions of Femoral Tunnel(3 months post-operative)
  • Aperture dimensions in femur(3 months post-operative)
  • Position of femoral tunnel(3 months post-operative)
  • Revascularisation and healing of ACL graft(12 months post-operative)

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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