Meniscus RuptureNCT04959292
Meniscus Regeneration After Meniscectomy and Its Clinical Significance
An observational study of Meniscus Rupture and Regeneration, run by Peking University Third Hospital at 1 site in China.
Trial summary
Meniscus injury is common in sports-active population, and partial or total meniscectomy is standard surgery for meniscal tear. Meniscus plays an important role in load transferring, shock absorbing, knee joint stabilizing and chondral protection. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Rupture, Regeneration
- What is being tested?
- arthroscopy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to Dec 2022
- How long will I take part?
- 10 Years
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: all the patients receving meniscectomy
Who may be able to join
- Patients intending to undergo single-knee ACL reconstruction at our Institute of Sports Medicine.
- The age of 18 ~ 50 years old at the time of operation.
- Both men and women.
- BMI < 24.
- Complete or partial meniscectomy was performed at the same time as ACL reconstruction.
- Patients willing to undergo a second arthroscopic exploration 2 years postoperatively and to take the portal screws used to fix the ligaments during the initial surgery.
- Patients with preserved meniscus video during ACL reconstruction.
- The degree of knee osteoarthritis (KOA) at the time of operation was < Ⅲ of Kellgren Laurence level.
Who cannot join
- Patients with severe knee cartilage injury.
- Patients with KOA≥KLⅢ at the time of operation.
- The patients cannot be followed up.
- Patients who refused the second arthroscopy and the removal of the internal fixation portal screw at the time of surgery.
- Patients with rheumatoid arthritis or other arthritis.
- Patients with other systemic diseases who take oral anti-inflammatory analgesics for years.
- Patients with multiple injections of drugs in the joint due to various reasons.
Trial locations and contacts
1 site in 1 country.
Jiakuo Yu, Professor contact
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
Official title: Meniscus Regeneration After Meniscectomy: Factors Predicting the Regeneration and the Clinical Significance of the Regenerated Meniscus
Meniscus injury is common in sports-active population, and partial or total meniscectomy is standard surgery for meniscal tear. Meniscus plays an important role in load transferring, shock absorbing, knee joint stabilizing and chondral protection. Plenty of studies indicate that meniscus-deficiency increases the risk of OA and cause long-term poor outcomes.
Spontaneous human meniscus regeneration is rarely reported and whether regenerated meniscus is chondral-protective and can prevent OA progression remain unknown. During our clinical practice, we have encountered many cases with complete meniscal regeneration under arthroscopy. In this study, we will include all the patients who receiving meniscectomy and ACL reconstruction and knee arthroscopy 2 years after primary surgery. Patients demographic characters will be reviewed. The resected meniscus in the primary surgery and biopsied regenerated meniscus will be analyzed by histological and immunohistochemical method and their ultrastructure will be observed by electron microscope. Patients will be followed at 2-, 5- and 10-year after the primary surgery and the cartilage degeneration and OA progression will be assessed.
- Conditions
- Meniscus Rupture, Regeneration
- Being tested
- arthroscopy
- Keywords
- meniscus, regeneration, meniscectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopyDiagnostic test
arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Meniscus regeneration | Reconstruction of the anterior cruciate ligament, total or partial meniscus resection was performed in our hospital, and two years after the operation, the meniscus regeneration was found under secondary arthroscopy. Receives: Diagnostic Test: arthroscopy | |
| Meniscus without regeneration | Anterior cruciate ligament reconstruction, total or partial meniscus resection was performed in our hospital, and two years after the operation, no meniscus regeneration was found under secondary arthroscopy. Receives: Diagnostic Test: arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
meniscus regeneration
the resected meniscus regeneration is found under the arthroscopy.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jun 2020
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus RuptureStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zimu Mao, Dortor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959292
- Sponsor's protocol ID
- M2019299
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meniscus Regeneration After Meniscectomy: Factors Predicting the Regeneration and the Clinical Significance of the Regenerated Meniscus
- ClinicalTrials.gov ID
- NCT04959292
- Acronym / sponsor ID
- M2019299
- Conditions
- Meniscus Rupture, Regeneration
- Keywords
- meniscus, regeneration, meniscectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 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.
Meniscus injury is common in sports-active population, and partial or total meniscectomy is standard surgery for meniscal tear. Meniscus plays an important role in load transferring, shock absorbing, knee joint stabilizing and chondral protection. Plenty of studies indicate that meniscus-deficiency increases the risk of OA and cause long-term poor outcomes.
Spontaneous human meniscus regeneration is rarely reported and whether regenerated meniscus is chondral-protective and can prevent OA progression remain unknown. During our clinical practice, we have encountered many cases with complete meniscal regeneration under arthroscopy. In this study, we will include all the patients who receiving meniscectomy and ACL reconstruction and knee arthroscopy 2 years after primary surgery. Patients demographic characters will be reviewed. The resected meniscus in the primary surgery and biopsied regenerated meniscus will be analyzed by histological and immunohistochemical method and their ultrastructure will be observed by electron microscope. Patients will be followed at 2-, 5- and 10-year after the primary surgery and the cartilage degeneration and OA progression will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meniscus regeneration | – | Diagnostic Test: arthroscopyReconstruction of the anterior cruciate ligament, total or partial meniscus resection was performed in our hospital, and two years after the operation, the meniscus regeneration was found under secondary arthroscopy. |
| Meniscus without regeneration | – | Diagnostic Test: arthroscopyAnterior cruciate ligament reconstruction, total or partial meniscus resection was performed in our hospital, and two years after the operation, no meniscus regeneration was found under secondary arthroscopy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all the patients receving meniscectomy
Key inclusion criteria (8 listed)
- Patients intending to undergo single-knee ACL reconstruction at our Institute of Sports Medicine.
- The age of 18 ~ 50 years old at the time of operation.
- Both men and women.
- BMI < 24.
- Complete or partial meniscectomy was performed at the same time as ACL reconstruction.
Key exclusion criteria (7 listed)
- Patients with severe knee cartilage injury.
- Patients with KOA≥KLⅢ at the time of operation.
- The patients cannot be followed up.
- Patients who refused the second arthroscopy and the removal of the internal fixation portal screw at the time of surgery.
- Patients with rheumatoid arthritis or other arthritis.
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 |
|---|---|---|
| arthroscopyarthroscopy | Diagnostic test | Meniscus regeneration, Meniscus without regeneration |
Primary outcome
meniscus regeneration
Time frame: 2 year
the resected meniscus regeneration is found under the arthroscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Jiakuo Yu, Professor contact
Zimu Mao, Dortor principal investigator
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 Rupture and Regeneration, 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 8 inclusion and 7 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 13 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 Zimu Mao, Doctor (13331031448, mzm@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meniscus regeneration (time frame: 2 year). 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 13 Jul 2021.