Clinical Application Research of Combined Therapy in ERAS for Accelerated Orthopedic Rehabilitation

NCT ID: NCT07273032

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2026-12-31

Brief Summary

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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.

1. 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.
2. 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.
3. 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.

Detailed Description

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Conditions

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Meniscus Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Blank control group

Underwent meniscus plasty under knee arthroscopy

Group Type SHAM_COMPARATOR

Blank control group

Intervention Type PROCEDURE

Underwent meniscus plasty under knee arthroscopy

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.

Group Type EXPERIMENTAL

Blank control group

Intervention Type PROCEDURE

Underwent meniscus plasty under knee arthroscopy

Henggu Bone Injury Healing Agent Intervention Group

Intervention Type DRUG

Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.

Lower limb rehabilitation training system intervention group

Intervention Type DEVICE

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.

Henggu Bone Injury Healing Agent Intervention Group

Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.

Group Type EXPERIMENTAL

Blank control group

Intervention Type PROCEDURE

Underwent meniscus plasty under knee arthroscopy

Henggu Bone Injury Healing Agent Intervention Group

Intervention Type DRUG

Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.

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.

Group Type EXPERIMENTAL

Blank control group

Intervention Type PROCEDURE

Underwent meniscus plasty under knee arthroscopy

Lower limb rehabilitation training system intervention group

Intervention Type DEVICE

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.

Interventions

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Blank control group

Underwent meniscus plasty under knee arthroscopy

Intervention Type PROCEDURE

Henggu Bone Injury Healing Agent Intervention Group

Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

(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.

Exclusion Criteria

Patients with severe obesity; (2) People with cognitive dysfunction (such as Alzheimer's disease); (3) Those with severe heart, liver or kidney insufficiency.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KY2025PJ202

Identifier Type: -

Identifier Source: org_study_id

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