OsteoarthritisNCT06707948
A Study on Different Treatments for Knee Osteoarthritis Caused by Damaged Roots of the Medial Meniscus.
An observational study of Osteoarthritis and Meniscus Lesion, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
Medial meniscus posterior root tears (MMPRT) account for 20% or more of all meniscus tears, but the diagnosis and treatment of this condition continues to plague the general population due to the complexity of the diagnosis and uncertainty of the treatment. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Osteoarthritis, Meniscus Lesion
- What is being tested?
- Arthroscopic meniscus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 15 Dec 2027
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with posterior root injuries of the medial meniscus
Who may be able to join
- Clinical diagnosis of posterior root tear of the medial meniscus;
- Patients with K-L classification ≤ grade II;
- The age range of 50-65 years old;
- International Cartilage Repair Society (ICRS) Modified Magnetic Resonance Imaging Grading System ≤ Grade 2;
- International Cartilage Repair Society (ICRS) arthroscopic grading system ≤ grade 2;
- Knee joint mobility ≥90°;
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- Inversion deformity ≤10°;
- Must be able to complete follow-up MRI within 2 years after knee meniscus surgery;
- Must be able to complete clinical data;
Who cannot join
- Can not participate in this study;
- Patients with concomitant meniscal injuries elsewhere;
- knee joint infection disease;
- Osteoporosis disease;
- Patients with previous history of knee surgery;
- Knee joint instability disease;
Show all 11Show fewer
- Severe KOA disease;
- Can not cooperate with MRI detection;
- Cannot tolerate the surgery;
- Those who cannot tolerate the arthroscopic knee surgery;
- Neuromuscular system pathology disease;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Different Treatment Strategies for Root Injury Behind the Medial Meniscus to Delay the Progression of Knee Osteoarthritis: a Prospective Cohort Study
Medial meniscus posterior root tears (MMPRT) account for 20% or more of all meniscus tears, but the diagnosis and treatment of this condition continues to plague the general population due to the complexity of the diagnosis and uncertainty of the treatment. Early as well as timely diagnosis and treatment is one of the effective ways to avoid accelerated knee degeneration. Based on this study, our team is going to conduct a clinical study on posterior medial meniscus tear, combining Magnetic Resonance Imaging(MRI) to dynamically assess the changes of meniscus and articular cartilage surface after the injury, and selecting a specific patient group to carry out different therapeutic interventions, which mainly include conservative treatment, partial meniscectomy, and meniscal repair, in order to clarify the effects of different treatment modalities on the articular cartilage after the posterior meniscus tear, and to help to delay the degeneration of knee joints. This is to clarify the effects of different treatment modalities on the articular cartilage after posterior medial meniscus tears and to provide appropriate advice for delaying the progression of osteoarthritis of the knee.
- Conditions
- Osteoarthritis, Meniscus Lesion
- Being tested
- Arthroscopic meniscus surgery
- Keywords
- posterior meniscus root lesion;Osteoarthrotis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic meniscus surgeryProcedure or surgery
Comparison of the incidence of osteoarthritis with conservative treatment as well as arthroscopic partial resection as well as arthroscopic repair surgery for a condition known as posterior meniscus root injury.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment group | Non-steroidal anti-inflammatory and analgesic drugs | |
| Arthroscopic partial meniscectomy group | Arthroscopically, the damaged free meniscus is trimmed, ground, and partially resected; Receives: Procedure: Arthroscopic meniscus surgery | |
| Arthroscopic meniscus suture repair group | Arthroscopic download of the posterior meniscus root injury, placement of sutures through the bone tunnel to fix the meniscus, and then cutting it with a knot to complete the meniscus suture repair. Receives: Procedure: Arthroscopic meniscus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of KOA
Measured: 30th November 2024 -30th November 2027
Secondary outcomes (1)
Articular cartilage T2-mapping value
Articular cartilage T2 mapping values, post-standardised range 0-1
Measured: 30th November 2024 -30th November 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinxian Yu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707948
- Sponsor's protocol ID
- IIT2024-109
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decide whether to share data based on the level of completion of the project
Publications
Jung YH, Choi NH, Oh JS, Victoroff BN. All-inside repair for a root tear of the medial meniscus using a suture anchor. Am J Sports Med. 2012 Jun;40(6):1406-11. doi: 10.1177/0363546512439181. Epub 2012 Mar 16.
PubMed 22427620Faucett SC, Geisler BP, Chahla J, Krych AJ, Kurzweil PR, Garner AM, Liu S, LaPrade RF, Pietzsch JB. Meniscus Root Repair vs Meniscectomy or Nonoperative Management to Prevent Knee Osteoarthritis After Medial Meniscus Root Tears: Clinical and Economic Effectiveness. Am J Sports Med. 2019 Mar;47(3):762-769. doi: 10.1177/0363546518755754. Epub 2018 Mar 8.
PubMed 29517925Chung KS, Ha JK, Yeom CH, Ra HJ, Jang HS, Choi SH, Kim JG. Comparison of Clinical and Radiologic Results Between Partial Meniscectomy and Refixation of Medial Meniscus Posterior Root Tears: A Minimum 5-Year Follow-up. Arthroscopy. 2015 Oct;31(10):1941-50. doi: 10.1016/j.arthro.2015.03.035. Epub 2015 Jun 18.
PubMed 26095821Allaire R, Muriuki M, Gilbertson L, Harner CD. Biomechanical consequences of a tear of the posterior root of the medial meniscus. Similar to total meniscectomy. J Bone Joint Surg Am. 2008 Sep;90(9):1922-31. doi: 10.2106/JBJS.G.00748.
PubMed 18762653Bin SI, Kim JM, Shin SJ. Radial tears of the posterior horn of the medial meniscus. Arthroscopy. 2004 Apr;20(4):373-8. doi: 10.1016/j.arthro.2004.01.004.
PubMed 15067276Ozkoc G, Circi E, Gonc U, Irgit K, Pourbagher A, Tandogan RN. Radial tears in the root of the posterior horn of the medial meniscus. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):849-54. doi: 10.1007/s00167-008-0569-z. Epub 2008 Jun 7.
PubMed 18536902Nakagawa Y, Mukai S, Sakai S, Nakamura R, Takahashi M, Nakagawa S. Preoperative diagnosis of knee cartilage, meniscal, and ligament injuries by magnetic resonance imaging. J Exp Orthop. 2023 Apr 20;10(1):47. doi: 10.1186/s40634-023-00595-y.
PubMed 37079120Cao G, Gao S, Xiong B. Application of quantitative T1, T2 and T2* mapping magnetic resonance imaging in cartilage degeneration of the shoulder joint. Sci Rep. 2023 Mar 20;13(1):4558. doi: 10.1038/s41598-023-31644-2.
PubMed 36941288Ozel MA, Ogul H, Koksal A, Kose M, Tuncer K, Eren S, Kantarci M. Detection of the glenoid bare spot by non-arthrographic MR imaging, conventional MR arthrography, and 3D high-resolution T1-weighted VIBE MR arthrography: comparison with CT arthrography. Eur Radiol. 2023 May;33(5):3276-3285. doi: 10.1007/s00330-023-09443-0. Epub 2023 Feb 16.
PubMed 36792853Nguyen JC, De Smet AA, Graf BK, Rosas HG. MR imaging-based diagnosis and classification of meniscal tears. Radiographics. 2014 Jul-Aug;34(4):981-99. doi: 10.1148/rg.344125202.
PubMed 25019436Anz AW, Branch EA, Saliman JD. Biomechanical comparison of arthroscopic repair constructs for meniscal root tears. Am J Sports Med. 2014 Nov;42(11):2699-706. doi: 10.1177/0363546514549445. Epub 2014 Sep 15.
PubMed 25225682Bhatia S, LaPrade CM, Ellman MB, LaPrade RF. Meniscal root tears: significance, diagnosis, and treatment. Am J Sports Med. 2014 Dec;42(12):3016-30. doi: 10.1177/0363546514524162. Epub 2014 Mar 12.
PubMed 24623276Lee OS, Lee SH, Lee YS. Comparison of the Radiologic, Arthroscopic, and Clinical Outcomes between Repaired versus Unrepaired Medial Meniscus Posterior Horn Root Tear During Open Wedge High Tibial Osteotomy. J Knee Surg. 2021 Jan;34(1):57-66. doi: 10.1055/s-0039-1692992. Epub 2019 Jul 9.
PubMed 31288272Krych AJ, Johnson NR, Mohan R, Hevesi M, Stuart MJ, Littrell LA, Collins MS. Arthritis Progression on Serial MRIs Following Diagnosis of Medial Meniscal Posterior Horn Root Tear. J Knee Surg. 2018 Aug;31(7):698-704. doi: 10.1055/s-0037-1607038. Epub 2017 Sep 26.
PubMed 28950387Hwang BY, Kim SJ, Lee SW, Lee HE, Lee CK, Hunter DJ, Jung KA. Risk factors for medial meniscus posterior root tear. Am J Sports Med. 2012 Jul;40(7):1606-10. doi: 10.1177/0363546512447792. Epub 2012 May 11.
PubMed 22582224
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Treatment Strategies for Root Injury Behind the Medial Meniscus to Delay the Progression of Knee Osteoarthritis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06707948
- Acronym / sponsor ID
- IIT2024-109
- Conditions
- Osteoarthritis, Meniscus Lesion
- Keywords
- posterior meniscus root lesion;Osteoarthrotis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 27 Nov 2024 (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.
Medial meniscus posterior root tears (MMPRT) account for 20% or more of all meniscus tears, but the diagnosis and treatment of this condition continues to plague the general population due to the complexity of the diagnosis and uncertainty of the treatment. Early as well as timely diagnosis and treatment is one of the effective ways to avoid accelerated knee degeneration. Based on this study, our team is going to conduct a clinical study on posterior medial meniscus tear, combining Magnetic Resonance Imaging(MRI) to dynamically assess the changes of meniscus and articular cartilage surface after the injury, and selecting a specific patient group to carry out different therapeutic interventions, which mainly include conservative treatment, partial meniscectomy, and meniscal repair, in order to clarify the effects of different treatment modalities on the articular cartilage after the posterior meniscus tear, and to help to delay the degeneration of knee joints. This is to clarify the effects of different treatment modalities on the articular cartilage after posterior medial meniscus tears and to provide appropriate advice for delaying the progression of osteoarthritis of the knee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment group | – | –Non-steroidal anti-inflammatory and analgesic drugs |
| Arthroscopic partial meniscectomy group | – | Procedure: Arthroscopic meniscus surgeryArthroscopically, the damaged free meniscus is trimmed, ground, and partially resected; |
| Arthroscopic meniscus suture repair group | – | Procedure: Arthroscopic meniscus surgeryArthroscopic download of the posterior meniscus root injury, placement of sutures through the bone tunnel to fix the meniscus, and then cutting it with a knot to complete the meniscus suture repair. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with posterior root injuries of the medial meniscus
Key inclusion criteria (9 listed)
- Clinical diagnosis of posterior root tear of the medial meniscus;
- Patients with K-L classification ≤ grade II;
- The age range of 50-65 years old;
- International Cartilage Repair Society (ICRS) Modified Magnetic Resonance Imaging Grading System ≤ Grade 2;
- International Cartilage Repair Society (ICRS) arthroscopic grading system ≤ grade 2;
Key exclusion criteria (11 listed)
- Can not participate in this study;
- Patients with concomitant meniscal injuries elsewhere;
- knee joint infection disease;
- Osteoporosis disease;
- Patients with previous history of knee surgery;
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 |
|---|---|---|
| Arthroscopic meniscus surgeryComparison of the incidence of osteoarthritis with conservative treatment as well as arthroscopic partial resection as well as arthroscopic repair surgery for a condition known as posterior meniscus root injury. | Procedure or surgery | Arthroscopic meniscus suture repair group, Arthroscopic partial meniscectomy group |
Primary outcome
the incidence of KOA
Time frame: 30th November 2024 -30th November 2027
1 secondary outcome
Articular cartilage T2-mapping value
Time frame: 30th November 2024 -30th November 2027
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 27 Nov 2024.
- Results publication: PubMed 22427620Jung YH, Choi NH, Oh JS, Victoroff BN. All-inside repair for a root tear of the medial meniscus using a suture anchor. Am J Sports Med. 2012 Jun;40(6):1406-11. doi: 10.1177/0363546512439181. Epub 2012 Mar 16.
- Results publication: PubMed 29517925Faucett SC, Geisler BP, Chahla J, Krych AJ, Kurzweil PR, Garner AM, Liu S, LaPrade RF, Pietzsch JB. Meniscus Root Repair vs Meniscectomy or Nonoperative Management to Prevent Knee Osteoarthritis After Medial Meniscus Root Tears: Clinical and Economic Effectiveness. Am J Sports Med. 2019 Mar;47(3):762-769. doi: 10.1177/0363546518755754. Epub 2018 Mar 8.
- Results publication: PubMed 26095821Chung KS, Ha JK, Yeom CH, Ra HJ, Jang HS, Choi SH, Kim JG. Comparison of Clinical and Radiologic Results Between Partial Meniscectomy and Refixation of Medial Meniscus Posterior Root Tears: A Minimum 5-Year Follow-up. Arthroscopy. 2015 Oct;31(10):1941-50. doi: 10.1016/j.arthro.2015.03.035. Epub 2015 Jun 18.
- Results publication: PubMed 18762653Allaire R, Muriuki M, Gilbertson L, Harner CD. Biomechanical consequences of a tear of the posterior root of the medial meniscus. Similar to total meniscectomy. J Bone Joint Surg Am. 2008 Sep;90(9):1922-31. doi: 10.2106/JBJS.G.00748.
- Results publication: PubMed 15067276Bin SI, Kim JM, Shin SJ. Radial tears of the posterior horn of the medial meniscus. Arthroscopy. 2004 Apr;20(4):373-8. doi: 10.1016/j.arthro.2004.01.004.
- Results publication: PubMed 18536902Ozkoc G, Circi E, Gonc U, Irgit K, Pourbagher A, Tandogan RN. Radial tears in the root of the posterior horn of the medial meniscus. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):849-54. doi: 10.1007/s00167-008-0569-z. Epub 2008 Jun 7.
- Results publication: PubMed 37079120Nakagawa Y, Mukai S, Sakai S, Nakamura R, Takahashi M, Nakagawa S. Preoperative diagnosis of knee cartilage, meniscal, and ligament injuries by magnetic resonance imaging. J Exp Orthop. 2023 Apr 20;10(1):47. doi: 10.1186/s40634-023-00595-y.
- Results publication: PubMed 36941288Cao G, Gao S, Xiong B. Application of quantitative T1, T2 and T2* mapping magnetic resonance imaging in cartilage degeneration of the shoulder joint. Sci Rep. 2023 Mar 20;13(1):4558. doi: 10.1038/s41598-023-31644-2.
- Results publication: PubMed 36792853Ozel MA, Ogul H, Koksal A, Kose M, Tuncer K, Eren S, Kantarci M. Detection of the glenoid bare spot by non-arthrographic MR imaging, conventional MR arthrography, and 3D high-resolution T1-weighted VIBE MR arthrography: comparison with CT arthrography. Eur Radiol. 2023 May;33(5):3276-3285. doi: 10.1007/s00330-023-09443-0. Epub 2023 Feb 16.
- Results publication: PubMed 25019436Nguyen JC, De Smet AA, Graf BK, Rosas HG. MR imaging-based diagnosis and classification of meniscal tears. Radiographics. 2014 Jul-Aug;34(4):981-99. doi: 10.1148/rg.344125202.
- Results publication: PubMed 25225682Anz AW, Branch EA, Saliman JD. Biomechanical comparison of arthroscopic repair constructs for meniscal root tears. Am J Sports Med. 2014 Nov;42(11):2699-706. doi: 10.1177/0363546514549445. Epub 2014 Sep 15.
- Results publication: PubMed 24623276Bhatia S, LaPrade CM, Ellman MB, LaPrade RF. Meniscal root tears: significance, diagnosis, and treatment. Am J Sports Med. 2014 Dec;42(12):3016-30. doi: 10.1177/0363546514524162. Epub 2014 Mar 12.
- Individual participant dataSharing planned: Undecided. Decide whether to share data based on the level of completion of the project
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Meniscus Lesion, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 9 inclusion and 11 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 27 Nov 2024. 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. 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 Haifeng Zhang, Ph.D (86-15216619279, haifeng.zhang@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of KOA (time frame: 30th November 2024 -30th November 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707948, which also lists 25 linked publications.
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 27 Nov 2024.