Clinical Application Research of Combined Therapy in ERAS for Accelerated Orthopedic Rehabilitation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- VAS score, Limb symmetry index (LSI), HSS score, Lysholm score, International Knee Documentation Committee Knee Score (IKDC score), range of motion (ROM).
研究概览
简要总结
The double-blind method is adopted.Case selection Patients who underwent meniscus repair surgery under knee arthroscopy at Li Huili Hospital Affiliated to Ningbo University, the 906th Hospital of the People's Liberation Army (Joint Logistic Support Force of the Chinese People's Liberation Army), and Yangming Hospital Affiliated to Ningbo University (Yuyao People's Hospital), with ages set at 20 to 65 years old, are planned to be included in a sample size of 120 cases based on previous research experience, divided into 4 groups. They were respectively: the blank control group, the Henggu Bone Injury Healing Agent intervention group, the lower limb rehabilitation training system intervention group, and the Henggu Bone injury Healing agent combined with the lower limb rehabilitation training system intervention group, with 30 cases in each group. Grouping was conducted using a double-blind method, with random grouping carried out by a third-party organization.
- Inclusion criteria: (1) The patient is conscious and aware of the content of this study; (2) Those with good compliance; (3) Possess good language communication skills.
- Exclusion criteria: (1) Severely obese patients; (2) People with cognitive dysfunction; (3) Those with relevant serious complications; (4) Those with severe heart, liver or kidney insufficiency.
- Exclusion criteria: Those who received intervention with other anti-inflammatory and analgesic drugs after the operation.
Criteria for terminating the study: Postoperative complications such as joint infection and deep vein thrombosis of the lower extremities occur after the operation.
Blank control group: No intervention measures Lower limb rehabilitation training system intervention group: Received rehabilitation system intervention after the operation Henggu Bone Injury Healing Agent Intervention Group: Take Henggu Bone Injury Healing Agent after the operation The combined intervention group: After the operation, they took Henggu bone injury Healing Agent and received rehabilitation system intervention The knee joint function and pain scores of each group, the implementation of the recovery plan, remote guidance of the rehabilitation system (applicable to the intervention group), and the duration of drug use: a total of 6 weeks of Henggu Bone Injury Healing Agent were evaluated at 1 day, 4 weeks, 3 months, and 6 months after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients with meniscus injury were conscious and aware of the content of this study. (2) Good compliance and cooperation with relevant drug treatments; (3) Possess good language communication skills.
排除标准
- •Patients with severe obesity; (2) People with cognitive dysfunction (such as Alzheimer's disease); (3) Those with severe heart, liver or kidney insufficiency.
研究组 & 干预措施
Blank control group
Underwent meniscus plasty under knee arthroscopy
干预措施: Blank control group (Procedure)
Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio
On the basis of undergoing meniscus formation surgery under knee arthroscopy, systematic intervention of lower limb rehabilitation training was received. After discharge, remote guidance for home rehabilitation was provided, and at the same time, Henggu bone Injury Healing Agent was started to be taken.
干预措施: Blank control group (Procedure)
Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio
On the basis of undergoing meniscus formation surgery under knee arthroscopy, systematic intervention of lower limb rehabilitation training was received. After discharge, remote guidance for home rehabilitation was provided, and at the same time, Henggu bone Injury Healing Agent was started to be taken.
干预措施: Henggu Bone Injury Healing Agent Intervention Group (Drug)
Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio
On the basis of undergoing meniscus formation surgery under knee arthroscopy, systematic intervention of lower limb rehabilitation training was received. After discharge, remote guidance for home rehabilitation was provided, and at the same time, Henggu bone Injury Healing Agent was started to be taken.
干预措施: Lower limb rehabilitation training system intervention group (Device)
Henggu Bone Injury Healing Agent Intervention Group
Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.
干预措施: Blank control group (Procedure)
Henggu Bone Injury Healing Agent Intervention Group
Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.
干预措施: Henggu Bone Injury Healing Agent Intervention Group (Drug)
Lower limb rehabilitation training system intervention group
On the basis of undergoing meniscus formation surgery under knee arthroscopy, systematic intervention of lower limb rehabilitation training was received, and remote guidance for home rehabilitation was provided upon discharge.
干预措施: Blank control group (Procedure)
Lower limb rehabilitation training system intervention group
On the basis of undergoing meniscus formation surgery under knee arthroscopy, systematic intervention of lower limb rehabilitation training was received, and remote guidance for home rehabilitation was provided upon discharge.
干预措施: Lower limb rehabilitation training system intervention group (Device)
结局指标
主要结局
VAS score, Limb symmetry index (LSI), HSS score, Lysholm score, International Knee Documentation Committee Knee Score (IKDC score), range of motion (ROM).
时间窗: The first day after the operation, 4 weeks after the operation, 3 months after the operation, and 6 months after the operation.
1.Visual Analogue Scale (VAS)Range: 0-10 points,Interpretation: 0 = no pain, 10 = worst possible pain.Directionality: Higher scores indicate more severe pain (worse outcome).2.Limb Symmetry Index (LSI)Range: 0-100%.Directionality: Higher scores indicate better limb symmetry (better outcome).3.Hospital for Special Surgery Knee Score (HSS)Range: 0-100 points,Directionality: Higher scores indicate better function (better outcome).4.Lysholm Knee Scoring ScaleRange: 0-100 points.Directionality: Higher scores indicate better knee function (better outcome).5.International Knee Documentation Committee Knee Score (IKDC)Range: 0-100 point,Directionality: Higher scores indicate better knee function (better outcome).6.Range of Motion (ROM)Range:0°-135°,Directionality: Higher values indicate greater mobility (better outcome).
次要结局
未报告次要终点