跳至主要内容
临床试验/NCT06522659
NCT06522659招募中不适用

Evaluation of Clinical and Radiographic Outcomes of Surgically Treated Multiligamentous Knee Injuries

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
International Knee Documentation Committee (IKDC)

研究概览

简要总结

Multiligament knee injuries are typically caused by high-energy mechanisms and are classified according to the number of ligaments involved using Schenk's classification (Knee Dislocation) into KD 1, KD 2, KD 3, and KD 4. These types of injuries can have devastating consequences on the individual's quality of life, affecting their ability to return to sports and perform daily activities.

In the literature, there is still no consensus on the management of these types of traumas, both due to the wide range of situations that can present to the orthopedic surgeon and the difficulty in their diagnostic and therapeutic framing. The main controversies concern the conservative or surgical management of the injuries and the timing of when to undertake surgical treatment, if at all.

The instability resulting from multiligament knee injuries is poorly tolerated by patients, who find their daily activities limited. It is also well known that this instability can dramatically accelerate the development of osteoarthritis, leading to the need for joint replacement surgery even in young individuals, thus increasing the likelihood of revisions and re-operations over time.

Due to the lack of standardized and satisfactory treatment, the economic cost of the outcomes of multiligament knee injuries is particularly high. A recent study by XXX showed that only XXX% of individuals are able to return to work. The rate of participation in sports is even lower, which has a long-term potential impact by increasing the risk of sedentary lifestyle-related diseases such as obesity, diabetes, and cardiovascular diseases.

The choice of surgical treatment aims to eliminate the patient's subjective feeling of instability and to repair, when possible, or reconstruct the injured ligament structures to reduce the risk of secondary osteoarthritis. Available studies in the literature are often case reports presenting short- and medium-term results of non-standardized surgical techniques with great heterogeneity in rehabilitation protocols, so the real long-term effectiveness of these treatments in terms of joint stability and osteoarthritis prevention is not known.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 65 years at the time of surgery
  • Male and female gender
  • Patients undergoing multiligamentous knee reconstruction from January 1, 2000, to December 31, 2019, at the Rizzoli Orthopedic Institute.

排除标准

  • Patients no longer reachable;
  • Patients who do not consent to be included in the study;
  • Pregnant women;
  • Presence of infection or hematologic, rheumatic, or coagulative disorders at the time of evaluation.

结局指标

主要结局

International Knee Documentation Committee (IKDC)

时间窗: 5 years

The IKDC form assesses knee function and symptoms across three domains: Symptoms (pain, stiffness, swelling, locking), Sports and daily activities, and Current knee function compared to before injury. It includes 10 questions: seven on symptoms, one on sports, one on daily activity difficulties, and one on current knee function. Scores range from 0 to 100, with higher scores indicating better knee function (excellent: 80-100, good: 60-80, fair: 30-60, poor: 0-30).

次要结局

  • Lysholm Knee Score(5 years)

研究者

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

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Istituto Ortopedico Rizzoli

研究点 (1)

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