跳至主要内容
临床试验/NCT07377669
NCT07377669Enrolling By Invitation不适用

A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
15
试验地点
1
主要终点
Tegner-Lysholm score

研究概览

简要总结

This study aims to collect datas about patient who underwent simultaneous monocompartimental knee replacement and anterior cruciate ligament recontruction

详细描述

The aim is to understand if anterior cruciate ligament recontruction is mandatory in case of monocompartimental knee replacement, given the fact that anterior stability could be compromised at first in ACL (anterior cruciate ligament) deficient knees. Current datas in literature are not sufficient to establish if ACL must always be recontructed or if only in some cases

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • monocompartimental knee arthrosis and ACL complete lesion
  • High functional request
  • Follow up >12 m
  • Complete clinical and radiographic documentation
  • Patients who accepted to partecipate to the study
  • Patients who did non underwent surgical procedures in the controlateral knee

排除标准

  • two stage surgeries (UKA and ACLr)
  • patients affected by neuromuscolar disorders, or psychomotor disorders
  • further knee ligamentous associated lesions
  • revision surgery
  • low functional request due to comorbilities

研究组 & 干预措施

UKA + LCA patients

Patients who underwent simultaneous anterior cruciate ligament and monocompartimental knee replacement

干预措施: UKA + ACLr (Procedure)

结局指标

主要结局

Tegner-Lysholm score

时间窗: 12 months after surgery

The Tegner Lysholm Knee Scoring Scale is a questionnaire used to assess knee function and symptoms, particularly in the context of ligament injuries of the knee. It evaluates eight categories: pain, swelling, instability, locking, limp, stair climbing, squatting, and need for support. Each category is scored, and the total score, out of 100, reflects overall knee function. Higher scores indicate better knee function.

次要结局

  • SF-36(12 months after surgery)
  • Ucla(12 months after surgery)
  • Return to Sport(12 months after surgery)
  • New KSS(12 months after surgery)
  • Vas(12 months after surgery)
  • KT-1000(12 months after surgery)
  • ROM(12 months after surgery)

研究者

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

Stefano Zaffagnini

Professor

Istituto Ortopedico Rizzoli

研究点 (1)

Loading locations...

相似试验