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临床试验/NCT06264076
NCT06264076招募中不适用

Ligament Balancing in Total Knee Arthroplasty - A Proof-of-Concept Study on a Systematic Approach to Bellemans Technique

Oslo University Hospital4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
4
主要终点
Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?

研究概览

简要总结

The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:

  1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
  2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?

Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital.

详细描述

Varus deformity is the most common deformity (60-80%) in patients undergoing total knee arthroplasty (TKA). In varus knees, there could be shortening of medial structures; therefore, if mechanical alignment is the goal, perpendicular bone cuts could produce a trapezoidal gap between the femur and tibia, with a shorter medial side. This imbalance should be corrected through ligament balancing as it is seen as a prerequisite for good function and survival. Aunan et al. found ligament balancing to be necessary in 70 of 100 consecutive TKAs.

Several ligament balancing techniques exist and most focus on lengthening the soft tissue on the concave side of the knee. Bellemans' and Whiteside's techniques are examples of ligament balancing procedures. In varus knees Bellemans' technique is performed with multiple perforations (pie-crusting) of the medial collateral ligament (MCL), while Whiteside's technique is performed with sequential ligament and soft tissue release, where the MCL is evaluated first. However, no technique has proved clinically superior to others. In traditional methods, it is difficult to reliably predict ligament lengthening and it relies on the performing surgeons' feel and experience. Aunan et al. found wide variation in lengthening achieved using Whiteside's technique. Therefore, the investigators have developed a novel device, which aspires to further develop Bellemans' technique and produce repeatable soft tissue lengthening of the MCL.

In varus knees the most important structure in ligament balancing is the superficial and deep MCL (hereafter MCL). Bellemans' technique is a proven technique, which uses an end-cutting cannula to puncture the MCL by freehand, with the objective of severing some ligament fibers. When the force applied to the ligament is kept constant, each remaining fiber will be exposed to a higher force and lengthen. Bellemans' technique lacks an objective method of guiding the puncturing, and the execution and results therefore vary. The novel instrument invented by the investigators, has a specific grid that objectively guides perpendicular puncturing using an end-cutting cannula and evenly distributes punctures throughout the ligament, which will produce a predefined spread of punctures and severing of fibers. The investigators believe this grid is key to achieving repeatable lengthening of the MCL, and promising results have been shown in porcine and human cadaveric tissue.

研究设计

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

盲法说明

Non-blind

入排标准

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

入选标准

  • Men and women over 40 years of age that require total knee arthroplasty
  • Idiopathic osteoarthrosis, osteonecrosis or avascular osteonecrosis
  • Otherwise fairly healthy/ no significant health issues

排除标准

  • Age under 40 years of age
  • Revisions or reoperations
  • Considerable earlier injury to the knee
  • Isolated patellofemoral osteoarthrosis

研究组 & 干预措施

Single interventional group at OUH Ullevål Hospital

Experimental

Singel group non-blin interventional study group receiving ligament balancing performed using a novel instrument. Ligament balancing will be evaluated using conventional instruments.

干预措施: Novel Instrument for ligament balancing in knee arthroplasty (Device)

Single interventional group at Bærum Hopsital Vestre Viken Hospital Trust

Experimental

Patients that need ligament balancing will receive the procedure using a novel instrument under knee arthroplasty surgery. BrainLab navigation will be used to evaluate ligament balancing. Performed av Bærum Hospital Vestre Viken Hospital Trust

干预措施: A novel instrument for ligament balancing in total knee arthroplasty (Device)

结局指标

主要结局

Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?

时间窗: 1 year

The investigators will be studying if it is possible to perform systematic ligament balancing on the MCL during total knee arthroplasty surgery, using a novel instrument.

Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?

时间窗: 1 year

The investigators will be studying if it is possible to perform systematic ligament balancing on the MCL during total knee arthroplasty surgery, using a novel instrument.

MCL-lengthening in millimeters after ligament balancing using the novel instrument

时间窗: 1 year

The investigators will be evaluating the amount of lengthening of the medial collateral ligament (MCL) in millimeters, that is achieved when using a novel instrument for systematic ligament balancing in total knee arthroplasty. Lengthening in millimeters is evaluated using computer navigated orthopaedic surgery (CAOS) and ligament tensioners or spatulas. The investigators will evaluate if the lengthening is linear and repeatable between individuals using regression analysis.

次要结局

  • Patient reported outcome measures (PROM) using EQ-5D-5L(1 year)
  • Demographic information - height (cm) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - weight (kg) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - age (years) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing.(1 year)
  • Patient reported outcome measures (PROM) using FJS-12(1 year)
  • Demographic information - height (cm) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - weight (kg) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - age (years) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing.(1 year)
  • Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing.(1 year)
  • Patient reported outcome measures (PROM) using EQ-5D-5L(1 year)
  • Patient reported outcome measures (PROM) using FJS-12(1 year)
  • Patient reported outcome measures (PROM) using KOOS(1 year)
  • Coronal plane angles(1 year)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lars Engseth

MD, orthopaedic consultant

Oslo University Hospital

研究点 (4)

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