Meniscus InjuryPhase 4NCT07273032
Clinical Application Research of Combined Therapy in ERAS for Accelerated Orthopedic Rehabilitation
A Phase 4 study testing Henggu Bone Injury Healing Agent Intervention Group and Lower limb rehabilitation training system intervention group in people with Meniscus Injury, run by Ningbo Medical Center Lihuili Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Meniscus Injury
- What is being tested?
- Henggu Bone Injury Healing Agent Intervention Group and Lower limb rehabilitation training system intervention group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with severe obesity; (2) People with cognitive dysfunction (such as Alzheimer's disease); (3) Those with severe heart, liver or kidney insufficiency.
About this study
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.
Read more
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.
- Conditions
- Meniscus Injury
- Being tested
- Blank control group, Henggu Bone Injury Healing Agent Intervention Group, Lower limb rehabilitation training system intervention group
- Keywords
- Patients who have undergone meniscus repair surgery under knee arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blank control groupProcedure or surgery
Underwent meniscus plasty under knee arthroscopy
Henggu Bone Injury Healing Agent Intervention GroupDrug
Patients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty.
Lower limb rehabilitation training system intervention groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Blank control group | Sham comparator | Underwent meniscus plasty under knee arthroscopy Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Blank control group; Device: Lower limb rehabilitation training system intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The first day after the operation, 4 weeks after the operation, 3 months after the operation, and 6 months after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273032
- Sponsor's protocol ID
- KY2025PJ202
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Research of Combined Therapy in ERAS for Accelerated Orthopedic Rehabilitation
- ClinicalTrials.gov ID
- NCT07273032
- Acronym / sponsor ID
- KY2025PJ202
- Conditions
- Meniscus Injury
- Keywords
- Patients who have undergone meniscus repair surgery under knee arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blank control group | Sham comparator | Procedure: Blank control groupUnderwent meniscus plasty under knee arthroscopy |
| Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio | Experimental | Procedure: Blank control group, Drug: Henggu Bone Injury Healing Agent Intervention Group, Device: Lower limb rehabilitation training system intervention groupOn 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. |
| Henggu Bone Injury Healing Agent Intervention Group | Experimental | Procedure: Blank control group, Drug: Henggu Bone Injury Healing Agent Intervention GroupPatients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty. |
| Lower limb rehabilitation training system intervention group | Experimental | Procedure: Blank control group, Device: Lower limb rehabilitation training system intervention groupOn 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with severe obesity; (2) People with cognitive dysfunction (such as Alzheimer's disease); (3) Those with severe heart, liver or kidney insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blank control groupUnderwent meniscus plasty under knee arthroscopy | Procedure or surgery | 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 GroupPatients received Henggu Bone Healing Formula concurrently after undergoing arthroscopic meniscal plasty. | Drug | 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 groupOn 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. | Device | Lower limb rehabilitation training system combined with Henggu bone Injury Healing Agent interventio, Lower limb rehabilitation training system intervention group |
Primary outcome
VAS score, Limb symmetry index (LSI), HSS score, Lysholm score, International Knee Documentation Committee Knee Score (IKDC score), range of motion (ROM).
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Meniscus Injury
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Recruiting
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Meniscus Lesion
Recruiting
Kinesiotaping in Isolated Meniscus Injuries
Meniscus Injury, Kinesio Taping
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruitingObservational study
Long-term Follow-up of Actifit® Meniscal Scaffold Patients.
Meniscus Lesion, Meniscus Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Henggu Bone Injury Healing Agent Intervention Group and Lower limb rehabilitation training system intervention group in people with Meniscus Injury, run by Ningbo Medical Center Lihuili Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score, Limb symmetry index (LSI), HSS score, Lysholm score, International Knee Documentation Committee Knee Score (IKDC score), range of motion (ROM). (time frame: The first day after the operation, 4 weeks after the operation, 3 months after the operation, and 6 months after the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.