Meniscus RegenerationNCT07885943
Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction
An observational study of Meniscus Regeneration and Partial Meniscectomy, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This study aims to employ 3.0T thin-slice high-resolution magnetic resonance imaging (MRI) and MIMICS image three-dimensionalreconstruction.Additionally, we examined the regeneration of the menisci in patients who had undergone partial meniscectomy of the knee joint at our hospital through retrospective follow-up and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Meniscus Regeneration, Partial Meniscectomy
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Research Subjects For patients who have undergone partial meniscectomy using arthroscopy at our hospital, as well as those planning to undergo a similar procedure at our facility. Patients who have undergone a surgical procedure.
Who may be able to join
- Patients who underwent partial resection of the meniscus using arthroscopy in our hospital and had follow-up thin-slice MRI scans within one week after surgery; no cases of joint infection, joint tumors, or other diseases were present.
Who cannot join
- Patients who did not undergo an MRI scan within one week after surgery for the removal of the inferior meniscus using arthroscopy, who had MRI scan contraindications or refused the procedure.
- Patients who underwent nuclear magnetic resonance (NMR) re-evaluation and had undergone surgery at least half a year prior to the commencement of this experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tsinghua Changgung Hospital, Beijing
Beijing, Beijing Municipality, 410006
Manting LIU Liu, +86 56118567, IRB@btch.edu.cn
About this study
This study aims to employ 3.0T thin-slice high-resolution magnetic resonance imaging (MRI) and MIMICS image three-dimensionalreconstruction.Additionally, we examined the regeneration of the menisci in patients who had undergone partial meniscectomy of the knee joint at our hospital through retrospective follow-up and meniscus segmentation techniques.
Proactive quantitative analysis of the meniscus in patients following partial meniscectomy of the knee joint 6 months and 12 months post-surgery.
The relationship between the percentage of regenerated tissue and the location and extent of the surgical excision.
Read the detailed description
1 Research Objectives
- Primary objectives: Quantitatively determine the percentage of meniscal regeneration in patients 6 months and 12 months post-surgery; evaluation. Identify the primary factors that influence or determine the regeneration of tissues, and explore clinical factors that may impact regeneration outcomes, such as age.The extent of the excision, the location of the excision, the inner or outer meniscus, and the degree of osteoarthritis, among other factors. Provides references for the selection of surgical methods.
- Secondary objective: To clarify the correlation between the extent of regeneration and knee joint function, and to correlate the degree of regeneration with knee joint function scores.
The ratios reveal the relationship between structural repair and functional improvement.
- Content of the Study The content of this study was based on a follow-up observation of patients who underwent partial meniscectomy at our hospital over a period of six months and one year after surgery.Thin-layer magnetic resonance imaging data acquisition, MIMICS image three-dimensional reconstruction and segmentation, precise quantification, and statistical analysis verification.Explore the decisive factors influencing meniscus regeneration.
3.Research design. This study is a bi-directional cohort study; it is a single-center study conducted in a single-blind format.
- Research Subjects For patients who have undergone partial meniscectomy using arthroscopy at our hospital, as well as those planning to undergo a similar procedure at our facility.Patients who have undergone a surgical procedure.
- Eligibility Criteria Patients who underwent partial resection of the meniscus using arthroscopy at our hospital and had follow-up thin-slice MRI scans within one week after surgery.Absence of joint infections, joint tumors, and other diseases that require joint fusion.
- Exclusion Criteria Patients who did not undergo an MRI scan within one week after surgery for the removal of the inferior meniscus using arthroscopy, who had MRI scan contraindications or refused the procedure.
Patients who underwent nuclear magnetic resonance (NMR) re-evaluation and had undergone surgery at least half a year prior to the commencement of this experiment.
- Intervention Methods This study is an observational study, and no additional therapeutic interventions were applied.
- Observation indicators and follow-up plan Observation indicator: The volume of meniscus regeneration measured through MRI 3D reconstruction at 6 months and 12 months post-surgery.
The results were compared to the volume of the meniscus at 1 week post-surgery. Additionally, a functional assessment of the knee joint (WOMET) was performed at corresponding time points.
Scoring tools, Lysholm scoring scale). Follow-up plan: Patients will be notified by phone to return to the hospital for a follow-up MRI examination 6 months and 12 months after surgery, during which their knee function will be evaluated.
The nuclear magnetic resonance (NMR) results were imported into MIMICS for image segmentation and reconstruction.
- Statistical analysis methodology
- . Data description and collation
- Methods: Use descriptive statistics.
- Content:
- For continuous variables that conform to a normal distribution (e.g. age, percentage of regeneration, function score), use the mean ± ± The standard deviation is described.
- For continuous variables that do not conform to a normal distribution, use the median (quarter-digit interval) to describe it.
- For classification variables (e.g. sex, type of injury), use frequency (percentage) to describe.
- Objective: To demonstrate clearly the basic characteristics of the study population and the distribution of data.
- . Analysis of key outcome indicators
- Method: Methods for managing clinical research projects initiated by researchers, 02 / 06 / 2020
- Analysis of repeated measurement variances.
- If the data does not meet the spherical hypothesis, the Greenhouse-Geisser method is used to correct it.
- Content: To compare the same group of patients at different time points (6 months vs. 12 months after surgery) Whether there is a statistical difference in the percentage of living volume.
- OBJECTIVE: To examine whether the regenerated tissue has changed significantly (such as atrophy or growth) from 6 months to 12 months after surgery. Assess its long-term stability. If the overall difference is significant, a second-to-second comparison will be made.
- . Analysis of secondary outcome indicators
- Method:
- a. The postoperative score was compared with the clinical good threshold using a single-sample t-test.
- b. Focus on correlation analysis (Spearman / Pearson) to explore the relationship between the percentage of postoperative regeneration and postoperative work A relationship that can be rated.
- c. Descriptive statistics were performed on postoperative functional scores to visually demonstrate the level of functional recovery.
- The choice of method depends on whether the score difference conforms to the normal distribution.
- Objective: To verify whether the surgery and regeneration process resulted in a significant improvement in clinical function.
- . Explore Analysis
- Method: Multivariate linear regression.
- Content: The percentage of regenerated volume 12 months after surgery is the dependent variable, which will likely affect factors (e.g. age, Body mass index BMI, medial or lateral meniscus, site of resection (body or posterior horn), extent of resection (margin or no margin) Methods for managing clinical research projects initiated by researchers, 02 / 06 / 2020 Page 11 of 25 Edge), percentage of regeneration 6 months after surgery, etc., were included as independent variables in the model.
- Objective: To explore independent predictors of final regenerative effects in a preliminary manner.
- . Statistical software and significance level
- Statistical Analysis Software: It will be done using professional accounting software, such as SPSS.
- Significance level: set to a = 0.05, that is, p < 0.05 considers the difference to be of general planning significance.
- Conditions
- Meniscus Regeneration, Partial Meniscectomy
- Being tested
- No intervention measures.
- Keywords
- Meniscus regeneration; Magnetic Resonance Imaging (MRI); Three-dimensional reconstruction; Volume quantification; Cohort study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention measures.Other
No intervention measures.
| Study group | Role | What they receive |
|---|---|---|
| Partial meniscectomy. | Patients who underwent partial meniscectomy at our hospital. Receives: Other: No intervention measures. | |
| Complete resection of the meniscus. | Patients who have undergone a complete resection of the meniscus due to a discoid meniscus or meniscal tear at our hospital. Receives: Other: No intervention measures. | |
| Complete resection of the meniscus + drilling of a bone channel. | Complete meniscectomy + anterior cruciate ligament reconstruction with drilling of an osteotomy channel. Receives: Other: No intervention measures. | |
| Partial meniscectomy + drilling of a bone channel. | Performed a partial meniscectomy + anterior cruciate ligament reconstruction with drilling of an osteotomy channel. Receives: Other: No intervention measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of regenerated volume of the partially resected meniscus after 6 months and 1 year post-surgery.
Measured: Six months and one year post-surgery.
Secondary outcomes (1)
Knee joint function assessment score.
Measured: Six months and one year post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus RegenerationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885943
- Sponsor's protocol ID
- 26045-4-01
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction
- ClinicalTrials.gov ID
- NCT07885943
- Acronym / sponsor ID
- 26045-4-01
- Conditions
- Meniscus Regeneration, Partial Meniscectomy
- Keywords
- Meniscus regeneration; Magnetic Resonance Imaging (MRI); Three-dimensional reconstruction; Volume quantification; Cohort study.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 21 Oct 2026 (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.
This study aims to employ 3.0T thin-slice high-resolution magnetic resonance imaging (MRI) and MIMICS image three-dimensionalreconstruction.Additionally, we examined the regeneration of the menisci in patients who had undergone partial meniscectomy of the knee joint at our hospital through retrospective follow-up and meniscus segmentation techniques.
Proactive quantitative analysis of the meniscus in patients following partial meniscectomy of the knee joint 6 months and 12 months post-surgery.
The relationship between the percentage of regenerated tissue and the location and extent of the surgical excision.
Detailed description
1 Research Objectives
- Primary objectives: Quantitatively determine the percentage of meniscal regeneration in patients 6 months and 12 months post-surgery; evaluation. Identify the primary factors that influence or determine the regeneration of tissues, and explore clinical factors that may impact regeneration outcomes, such as age.The extent of the excision, the location of the excision, the inner or outer meniscus, and the degree of osteoarthritis, among other factors. Provides references for the selection of surgical methods.
- Secondary objective: To clarify the correlation between the extent of regeneration and knee joint function, and to correlate the degree of regeneration with knee joint function scores.
The ratios reveal the relationship between structural repair and functional improvement.
- Content of the Study The content of this study was based on a follow-up observation of patients who underwent partial meniscectomy at our hospital over a period of six months and one year after surgery.Thin-layer magnetic resonance imaging data acquisition, MIMICS image three-dimensional reconstruction and segmentation, precise quantification, and statistical analysis verification.Explore the decisive factors influencing meniscus regeneration.
3.Research design. This study is a bi-directional cohort study; it is a single-center study conducted in a single-blind format.
- Research Subjects For patients who have undergone partial meniscectomy using arthroscopy at our hospital, as well as those planning to undergo a similar procedure at our facility.Patients who have undergone a surgical procedure.
- Eligibility Criteria Patients who underwent partial resection of the meniscus using arthroscopy at our hospital and had follow-up thin-slice MRI scans within one week after surgery.Absence of joint infections, joint tumors, and other diseases that require joint fusion.
- Exclusion Criteria Patients who did not undergo an MRI scan within one week after surgery for the removal of the inferior meniscus using arthroscopy, who had MRI scan contraindications or refused the procedure.
Patients who underwent nuclear magnetic resonance (NMR) re-evaluation and had undergone surgery at least half a year prior to the commencement of this experiment.
- Intervention Methods This study is an observational study, and no additional therapeutic interventions were applied.
- Observation indicators and follow-up plan Observation indicator: The volume of meniscus regeneration measured through MRI 3D reconstruction at 6 months and 12 months post-surgery.
The results were compared to the volume of the meniscus at 1 week post-surgery. Additionally, a functional assessment of the knee joint (WOMET) was performed at corresponding time points.
Scoring tools, Lysholm scoring scale). Follow-up plan: Patients will be notified by phone to return to the hospital for a follow-up MRI examination 6 months and 12 months after surgery, during which their knee function will be evaluated.
The nuclear magnetic resonance (NMR) results were imported into MIMICS for image segmentation and reconstruction.
- Statistical analysis methodology
- . Data description and collation
- Methods: Use descriptive statistics.
- Content:
- For continuous variables that conform to a normal distribution (e.g. age, percentage of regeneration, function score), use the mean ± ± The standard deviation is described.
- For continuous variables that do not conform to a normal distribution, use the median (quarter-digit interval) to describe it.
- For classification variables (e.g. sex, type of injury), use frequency (percentage) to describe.
- Objective: To demonstrate clearly the basic characteristics of the study population and the distribution of data.
- . Analysis of key outcome indicators
- Method: Methods for managing clinical research projects initiated by researchers, 02 / 06 / 2020
- Analysis of repeated measurement variances.
- If the data does not meet the spherical hypothesis, the Greenhouse-Geisser method is used to correct it.
- Content: To compare the same group of patients at different time points (6 months vs. 12 months after surgery) Whether there is a statistical difference in the percentage of living volume.
- OBJECTIVE: To examine whether the regenerated tissue has changed significantly (such as atrophy or growth) from 6 months to 12 months after surgery. Assess its long-term stability. If the overall difference is significant, a second-to-second comparison will be made.
- . Analysis of secondary outcome indicators
- Method:
- a. The postoperative score was compared with the clinical good threshold using a single-sample t-test.
- b. Focus on correlation analysis (Spearman / Pearson) to explore the relationship between the percentage of postoperative regeneration and postoperative work A relationship that can be rated.
- c. Descriptive statistics were performed on postoperative functional scores to visually demonstrate the level of functional recovery.
- The choice of method depends on whether the score difference conforms to the normal distribution.
- Objective: To verify whether the surgery and regeneration process resulted in a significant improvement in clinical function.
- . Explore Analysis
- Method: Multivariate linear regression.
- Content: The percentage of regenerated volume 12 months after surgery is the dependent variable, which will likely affect factors (e.g. age, Body mass index BMI, medial or lateral meniscus, site of resection (body or posterior horn), extent of resection (margin or no margin) Methods for managing clinical research projects initiated by researchers, 02 / 06 / 2020 Page 11 of 25 Edge), percentage of regeneration 6 months after surgery, etc., were included as independent variables in the model.
- Objective: To explore independent predictors of final regenerative effects in a preliminary manner.
- . Statistical software and significance level
- Statistical Analysis Software: It will be done using professional accounting software, such as SPSS.
- Significance level: set to a = 0.05, that is, p < 0.05 considers the difference to be of general planning significance.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Partial meniscectomy. | – | Other: No intervention measures.Patients who underwent partial meniscectomy at our hospital. |
| Complete resection of the meniscus. | – | Other: No intervention measures.Patients who have undergone a complete resection of the meniscus due to a discoid meniscus or meniscal tear at our hospital. |
| Complete resection of the meniscus + drilling of a bone channel. | – | Other: No intervention measures.Complete meniscectomy + anterior cruciate ligament reconstruction with drilling of an osteotomy channel. |
| Partial meniscectomy + drilling of a bone channel. | – | Other: No intervention measures.Performed a partial meniscectomy + anterior cruciate ligament reconstruction with drilling of an osteotomy channel. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Research Subjects For patients who have undergone partial meniscectomy using arthroscopy at our hospital, as well as those planning to undergo a similar procedure at our facility. Patients who have undergone a surgical procedure.
Key inclusion criteria (1 listed)
- Patients who underwent partial resection of the meniscus using arthroscopy in our hospital and had follow-up thin-slice MRI scans within one week after surgery; no cases of joint infection, joint tumors, or other diseases were present.
Key exclusion criteria (2 listed)
- Patients who did not undergo an MRI scan within one week after surgery for the removal of the inferior meniscus using arthroscopy, who had MRI scan contraindications or refused the procedure.
- Patients who underwent nuclear magnetic resonance (NMR) re-evaluation and had undergone surgery at least half a year prior to the commencement of this experiment.
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 |
|---|---|---|
| No intervention measures.No intervention measures. | Other | Complete resection of the meniscus + drilling of a bone channel., Complete resection of the meniscus., Partial meniscectomy + drilling of a bone channel., Partial meniscectomy. |
Primary outcome
Percentage of regenerated volume of the partially resected meniscus after 6 months and 1 year post-surgery.
Time frame: Six months and one year post-surgery.
1 secondary outcome
Knee joint function assessment score.
Time frame: Six months and one year post-surgery.
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 21 Oct 2026.
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.
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 Regeneration and Partial Meniscectomy, run by Beijing Tsinghua Chang Gung 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 2 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
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?
Contact Jiwen LONG (+86 13975982156, 1363477686@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of regenerated volume of the partially resected meniscus after 6 months and 1 year post-surgery. (time frame: Six months and one year post-surgery.). 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 21 Oct 2026.