跳至主要内容
临床试验/NCT03448198
NCT03448198已完成不适用

Validation of a New Technique for the Evaluation of the Patello-femoral Joint Kinematics

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Knee prosthesis translational alignment

研究概览

简要总结

The objective of this study is to validate a new technique for intraoperative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.

详细描述

In total knee replacement with patellar resurfacing, the patellar bone preparation and relevant component positioning, including relevant motion assessments, are still not navigated, and only femoral/tibial component positioning is supported by computer-assistance. After surgery, anterior knee pain is generally reported and this may due to prosthesis component mal-positioning, including the patella, and, ultimately, this may result in revision arthroplasty. Within computer-assisted surgery, surgical navigated system have been introduced to monitor femur and tibia prosthesis implantation and to assess tibio-femoral joint kinematics. In this context, the patella is still disregarded or limitedly considered, whereas it is still debated if the patella should be resurfaced in total knee replacement. Recently, new navigation-based procedures have been tested to allow the intra-operative monitoring of patellar-based data for more proper patellar resurfacing; at follow-up under active conditions, video-fluoroscopy, so far used to assess general tibio-femoral kinematics, offers the potentials for patellar motion tracking.

The possibility in vivo to perform intra-operative evaluations of the patello-femoral joint data, i.e. including patellar bone morphology and motion, via computer assisted procedures during surgery would allow the surgeon to have a more complete comprehension of the knee functioning in patients undergoing total knee replacement; these procedures, along with derived data, can act as a support in for the most critical surgical actions in terms of femoral/tibial prosthesis component implantation and related patellar resurfacing. Furthermore, at post-operative follow-ups via fluoroscopic acquisitions and gait analysis, it is possible to evaluate how the implant is able to recover, or not, the normative physiological motion at both tibio-femoral and patello-femoral joint.

The goal of this study is to validate a new technique for intra-operative quantification of the patello-femoral joint kinematics in patients undergoing total knee replacement, and for postoperative quantification of implanted knee and general lower limb activity, along with relevant muscle dynamics.

研究设计

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

盲法说明

open label

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients with unilateral primary knee arthrosis indicated for total knee replacement.
  • •Patients able to understand the protocol and to sign the informed consent.

排除标准

  • •Patients with indications for revision surgery.
  • •Patients with patellectomy.
  • •Child-bearing female.

研究组 & 干预措施

Knee arthritis

Other

Total knee replacement

干预措施: Total knee replacement (Procedure)

结局指标

主要结局

Knee prosthesis translational alignment

时间窗: At time of surgery

Translational (in mm) positioning of femur, tibia and patella prosthesis components.

Knee prosthesis rotational alignment

时间窗: At time of surgery

Rotational (in deg) positioning of femur, tibia and patella prosthesis components.

次要结局

  • Post-operative knee joint translations(24 months)
  • Post-operative knee joint rotations(24 months)
  • Intra-operative knee joint translations(At time of surgery)
  • Intra-operative knee joint rotations(At time of surgery)

研究者

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

Claudio Belvedere

PhD

Istituto Ortopedico Rizzoli

研究点 (1)

Loading locations...

相似试验