Meniscus InjuryNCT04962555
Clinical Related Study on Surgical Treatment of Knee Joint Meniscus Injury
An observational study of Meniscus Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
Through the analysis of the data of 8094 patients with knee meniscus injury before December 31, 2008 and more patients with partial meniscus resection, subtotal resection and total resection, we can understand the gender difference and ratio of medial and lateral meniscus injuries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meniscus Injury
- What is being tested?
- Meniscus Suture, Partial meniscus resection and Subtotal meniscus resection
- Type of treatment
- Surgery or procedure
- How many people
- 8,778 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 8778 patients with meniscus injury who underwent surgery at the Institute of Sports Medicine of the Third Hospital of Peking University before December 31, 2008 and patients who underwent meniscus suture, partial resection, subtotal resection, or total resection afterwards
Who may be able to join
- Before December 31, 2008, patients who underwent surgery for meniscus injury in this institute and patients who underwent meniscus suture, partial resection, subtotal resection, and total resection.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jia-kuo Yu, MD, 86-10-82267392, yujiakuo@126.com
About this study
Through the analysis of the data of 8094 patients with knee meniscus injury before December 31, 2008 and more patients with partial meniscus resection, subtotal resection and total resection, we can understand the gender difference and ratio of medial and lateral meniscus injuries. Differences, differences in locations, differences in tearing methods, differences in surgical methods, and the course of the disease affect the meniscus injury and surgical methods, and further affect the patient's knee degeneration imaging, accompanying cartilage injury, knee osteoarthritis, Partial resection, subtotal resection and meniscus regeneration after total resection, imaging and secondary arthroscopic exploration (Second-Look) were studied.
Read the detailed description
Through the data of 8094 patients with knee meniscus injury who underwent surgery at the Institute of Sports Medicine of the Third Hospital of Beijing Medical University before December 31, 2008, and the patients who underwent meniscus suture, partial resection, subtotal resection, and total resection. Analyze and understand the influence of gender difference, ratio difference, position difference, tearing method difference, surgical method difference and disease course on the meniscus injury situation and operation method of the internal and lateral meniscus injury. Observation and research will also be conducted on reports of knee cartilage injury, knee osteoarthritis, and meniscus regeneration after partial meniscus resection, subtotal resection and total resection.
- Conditions
- Meniscus Injury
- Being tested
- Meniscus Suture, Partial meniscus resection, Subtotal meniscus resection, Complete meniscectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscus SutureProcedure or surgery
Patients with knee joint meniscus injury undergoing meniscus suture
Partial meniscus resectionProcedure or surgery
Patients with knee joint meniscus injury undergoing partial meniscus resection
Subtotal meniscus resectionProcedure or surgery
Patients with knee joint meniscus injury undergoing subtotal meniscus resection
Complete meniscectomyProcedure or surgery
Patients with knee joint meniscus injury undergoing complete meniscectomy
| Study group | Role | What they receive |
|---|---|---|
| Meniscus Suture | The patient underwent meniscus suture surgery Receives: Procedure: Meniscus Suture | |
| Partial meniscus resection | The patient underwent partial meniscus resection Receives: Procedure: Partial meniscus resection | |
| Subtotal meniscus resection | The patient underwent Subtotal meniscus resection Receives: Procedure: Subtotal meniscus resection | |
| Complete meniscectomy | The patient underwent complete meniscectomy Receives: Procedure: Complete meniscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meniscus injury site
Observe the meniscus injury site during the operation, which is divided into: medial and lateral anterior horn, medial and lateral body, medial and lateral posterior horn, medial and lateral disc.
Measured: During operation
Types of Meniscus Injury
The types of meniscus injuries were observed during the operation, which were divided into longitudinal fissure, oblique fissure, spallation, radial fissure, and barrel shank tear.
Measured: During operation
Meniscus surgery method
Meniscus surgery methods include: partial resection, subtotal resection, total resection, and suture.
Measured: During operation
Cartilage damage
The cartilage damage is evaluated as yes or no, where the cartilage surface is smooth and complete is defined as no, and the rest is defined as yes.
Measured: During operation
Cartilage damage
Second-look after operation to observe whether the cartilage is damaged. The cartilage damage is evaluated as yes or no, where the cartilage surface is smooth and complete is defined as no, and the rest is defined as yes.
Measured: 7 years after surgery
Meniscus regeneration
Second-look after operation to observe whether the meniscus is regenerating. The Meniscus regeneration is evaluated as yes or no, in which the meniscus shape is complete and no tear is defined as yes, and other conditions are defined as no.
Measured: 7 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Aug 2016
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia-kuo Yu, Prof., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962555
- Sponsor's protocol ID
- IRB00006761-2015159
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Related Study on Surgical Treatment of Knee Joint Meniscus Injury
- ClinicalTrials.gov ID
- NCT04962555
- Acronym / sponsor ID
- IRB00006761-2015159
- Conditions
- Meniscus Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,778 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Jul 2021 (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.
Through the analysis of the data of 8094 patients with knee meniscus injury before December 31, 2008 and more patients with partial meniscus resection, subtotal resection and total resection, we can understand the gender difference and ratio of medial and lateral meniscus injuries. Differences, differences in locations, differences in tearing methods, differences in surgical methods, and the course of the disease affect the meniscus injury and surgical methods, and further affect the patient's knee degeneration imaging, accompanying cartilage injury, knee osteoarthritis, Partial resection, subtotal resection and meniscus regeneration after total resection, imaging and secondary arthroscopic exploration (Second-Look) were studied.
Detailed description
Through the data of 8094 patients with knee meniscus injury who underwent surgery at the Institute of Sports Medicine of the Third Hospital of Beijing Medical University before December 31, 2008, and the patients who underwent meniscus suture, partial resection, subtotal resection, and total resection. Analyze and understand the influence of gender difference, ratio difference, position difference, tearing method difference, surgical method difference and disease course on the meniscus injury situation and operation method of the internal and lateral meniscus injury. Observation and research will also be conducted on reports of knee cartilage injury, knee osteoarthritis, and meniscus regeneration after partial meniscus resection, subtotal resection and total resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Meniscus Suture | – | Procedure: Meniscus SutureThe patient underwent meniscus suture surgery |
| Partial meniscus resection | – | Procedure: Partial meniscus resectionThe patient underwent partial meniscus resection |
| Subtotal meniscus resection | – | Procedure: Subtotal meniscus resectionThe patient underwent Subtotal meniscus resection |
| Complete meniscectomy | – | Procedure: Complete meniscectomyThe patient underwent complete meniscectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 8778 patients with meniscus injury who underwent surgery at the Institute of Sports Medicine of the Third Hospital of Peking University before December 31, 2008 and patients who underwent meniscus suture, partial resection, subtotal resection, or total resection afterwards
Key inclusion criteria (1 listed)
- Before December 31, 2008, patients who underwent surgery for meniscus injury in this institute and patients who underwent meniscus suture, partial resection, subtotal resection, and total resection.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Meniscus SuturePatients with knee joint meniscus injury undergoing meniscus suture | Procedure or surgery | Meniscus Suture |
| Partial meniscus resectionPatients with knee joint meniscus injury undergoing partial meniscus resection | Procedure or surgery | Partial meniscus resection |
| Subtotal meniscus resectionPatients with knee joint meniscus injury undergoing subtotal meniscus resection | Procedure or surgery | Subtotal meniscus resection |
| Complete meniscectomyPatients with knee joint meniscus injury undergoing complete meniscectomy | Procedure or surgery | Complete meniscectomy |
Primary outcome
Meniscus injury site
Time frame: During operation
Observe the meniscus injury site during the operation, which is divided into: medial and lateral anterior horn, medial and lateral body, medial and lateral posterior horn, medial and lateral disc.
Types of Meniscus Injury
Time frame: During operation
The types of meniscus injuries were observed during the operation, which were divided into longitudinal fissure, oblique fissure, spallation, radial fissure, and barrel shank tear.
Meniscus surgery method
Time frame: During operation
Meniscus surgery methods include: partial resection, subtotal resection, total resection, and suture.
Cartilage damage
Time frame: During operation
The cartilage damage is evaluated as yes or no, where the cartilage surface is smooth and complete is defined as no, and the rest is defined as yes.
Cartilage damage
Time frame: 7 years after surgery
Second-look after operation to observe whether the cartilage is damaged. The cartilage damage is evaluated as yes or no, where the cartilage surface is smooth and complete is defined as no, and the rest is defined as yes.
Meniscus regeneration
Time frame: 7 years after surgery
Second-look after operation to observe whether the meniscus is regenerating. The Meniscus regeneration is evaluated as yes or no, in which the meniscus shape is complete and no tear is defined as yes, and other conditions are defined as no.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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. This study is not recruiting at the moment.
Jia-kuo Yu, Prof. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Injury, run by Peking University Third Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-kuo Yu, Prof. (+86 13331031448, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meniscus injury site (time frame: During operation). The study lists 6 primary outcomes in all. 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 15 Jul 2021.