Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction

NCT07885943 — Recruiting, 120 participants, Beijing Tsinghua Chang Gung Hospital

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RegistryNCT07885943
StatusRecruiting
Study typeObservational
Enrollment120 (Estimated)
SponsorBeijing Tsinghua Chang Gung Hospital (Other)
ConditionsMeniscus Regeneration, Partial Meniscectomy
InterventionsNo intervention measures. (Other)
Datesstart 2024-01-01, primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Meniscus Regeneration All trials for Partial Meniscectomy All trials of No intervention measures.

-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 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.

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+Detailed description

1 Research Objectives

1. 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.
2. 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.

2\. 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.

4\. 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.

5\. 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.

6\. 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.

7\. Intervention Methods This study is an observational study, and no additional therapeutic interventions were applied.

8\. 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.

9\. Statistical analysis methodology

1. . 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.
2. . 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.
3. . 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.
4. . 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.
5. . 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.

+Arms and interventions

ArmTypeInterventionsDescription
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.
  • No intervention measures. (Other): No intervention measures.

+Outcome measures

Primary outcomes

  • Percentage of regenerated volume of the partially resected meniscus after 6 months and 1 year post-surgery. [Six months and one year post-surgery.]

Secondary outcomes

  • Knee joint function assessment score. [Six months and one year post-surgery.]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* 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.

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.

+Locations (1)

FacilityCityCountryStatus
Tsinghua Changgung Hospital, BeijingBeijing, Beijing MunicipalityChinaRecruiting