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

NCT07273032 | Not Yet Recruiting Phase 4

• 1 other identifier: KY2025PJ202
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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. 3.Exclusion criteria: Those who received intervention with other anti-inflammatory and analgesic drugs after the operation.

Conditions

Meniscus Injury

Keywords

Patients who have undergone meniscus repair surgery under knee arthroscopy

Outcome Measures

Primary Outcomes (1)

• VAS score, Limb symmetry index (LSI), HSS score, Lysholm score, International Knee Documentation Committee Knee Score (IKDC score), range of motion (ROM).

  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).

  The first day after the operation, 4 weeks after the operation, 3 months after the operation, and 6 months after the operation.

Study Arms (4)

Blank control group

SHAM COMPARATOR

Underwent meniscus plasty under knee arthroscopy

Procedure: Blank control group

Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio

EXPERIMENTAL

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.

Procedure: Blank control group; Drug: Henggu Bone Injury Healing Agent Intervention Group; Device: Lower limb rehabilitation training system intervention group

Henggu Bone Injury Healing Agent Intervention Group

EXPERIMENTAL

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

Procedure: Blank control group; Drug: Henggu Bone Injury Healing Agent Intervention Group

Lower limb rehabilitation training system intervention group

EXPERIMENTAL

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.

Procedure: Blank control group; Device: Lower limb rehabilitation training system intervention group

Interventions

Blank control group PROCEDURE

Underwent meniscus plasty under knee arthroscopy

Blank control group; Henggu Bone Injury Healing Agent Intervention Group; Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio; Lower limb rehabilitation training system intervention group

Henggu Bone Injury Healing Agent Intervention Group DRUG

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

Henggu Bone Injury Healing Agent Intervention Group; Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio

Lower limb rehabilitation training system intervention group 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.

Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio; Lower limb rehabilitation training system intervention group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: December 9, 2025
• Study Start: December 30, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share