Medial Mensical TearRoot TearsNCT05971472
Arthroscopic Repair Versus High Tibial Osteotomy for Medial Meniscus Posterior Root Tears
A study testing Arthroscopic Repair and High tibial osteotomy in people with Medial Mensical Tear, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial osteotomy for Medial Meniscus posterior root tears Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Medial Mensical Tear
- What is being tested?
- Arthroscopic Repair and High tibial osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2021to Dec 2024
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: both sexes.
- Age: Above 40
- Degree of Varus: Neutral to 10 degrees of Varus
Who cannot join
- History of high energy trauma.
- Multiligamentous knee Injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Repair Versus Opening Wedge High Tibial Osteotomy for Medial Meniscus Posterior Root Tears
The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial osteotomy for Medial Meniscus posterior root tears
Read the detailed description
All Patients included in this clinical trial will be informed by written consent will undergo a one week screening to determine the eligibility for study entry.
Patients who meet the eligibility requirements will be randomized in a single blinded manner (patients).
- Conditions
- Medial Mensical Tear
- Being tested
- Arthroscopic Repair, High tibial osteotomy
- Keywords
- Medial, Meniscus, Posterior, Root, Tear, High Tibial Osteotomy, Arthroscopic Root Repair, Transtibial Pullout, Arthroscopic Repair, Open Wedge
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic RepairProcedure or surgery
Arthroscopic Repair for medial meniscus posterior Root tears
High tibial osteotomyProcedure or surgery
Open Wedge High tibial osteotomy for medial meniscus posterior Root tears
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Repair | Active comparator | Arthroscopic Repair for medial meniscus posterior root tears Receives: Procedure: Arthroscopic Repair |
| High tibial osteotomy | Active comparator | Open wedge High tibial osteotomy for medial meniscus posterior root tears Receives: Procedure: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Score
Validated Arabic form of Lyshlom score
Measured: 3 month and 6 month
IKDC Score
Validated Arabic form of IKDC score
Measured: 3 month and 6 month
Secondary outcomes (3)
infection
Occurrence of infection
Measured: 3 month and 6 month
Non union
Occurrence of delayed or non union
Measured: 3 month and 6 month
Arthrofibrosis
Loss of knee ROM or occurrence of Arthrofibrosis
Measured: 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start12 Sep 2021
- Primary completionSep 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medial Mensical TearStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael S. Abdel Megid, Professor, Study director, Ain Shams UniversityZeiad M. Zakaria, Assistant Professor, Study director, Ain Shams UniversityRadwan G. Abdel Hamid, Assistant Professor, Study director, Ain Shams UniversityMohamed E. Awad, Assistant Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971472
- Sponsor's protocol ID
- FMASU MD 169/2021
- Acronym
- Root Tears
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim KI, Bae JK, Jeon SW, Kim GB. Medial Meniscus Posterior Root Tear Does Not Affect the Outcome of Medial Open-Wedge High Tibial Osteotomy. J Arthroplasty. 2021 Feb;36(2):423-428. doi: 10.1016/j.arth.2020.08.067. Epub 2020 Sep 7.
PubMed 32978022Nha KW, Lee YS, Hwang DH, Kwon JH, Chae DJ, Park YJ, Kim JI. Second-look arthroscopic findings after open-wedge high tibia osteotomy focusing on the posterior root tears of the medial meniscus. Arthroscopy. 2013 Feb;29(2):226-31. doi: 10.1016/j.arthro.2012.08.027.
PubMed 23369476Marzo JM, Gurske-DePerio J. Effects of medial meniscus posterior horn avulsion and repair on tibiofemoral contact area and peak contact pressure with clinical implications. Am J Sports Med. 2009 Jan;37(1):124-9. doi: 10.1177/0363546508323254. Epub 2008 Sep 24.
PubMed 18815238Feucht MJ, Kuhle J, Bode G, Mehl J, Schmal H, Sudkamp NP, Niemeyer P. Arthroscopic Transtibial Pullout Repair for Posterior Medial Meniscus Root Tears: A Systematic Review of Clinical, Radiographic, and Second-Look Arthroscopic Results. Arthroscopy. 2015 Sep;31(9):1808-16. doi: 10.1016/j.arthro.2015.03.022. Epub 2015 May 13.
PubMed 25979687
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Repair Versus Opening Wedge High Tibial Osteotomy for Medial Meniscus Posterior Root Tears
- ClinicalTrials.gov ID
- NCT05971472
- Acronym / sponsor ID
- Root Tears / FMASU MD 169/2021
- Conditions
- Medial Mensical Tear
- Keywords
- Medial, Meniscus, Posterior, Root, Tear, High Tibial Osteotomy, Arthroscopic Root Repair, Transtibial Pullout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Aug 2023 (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.
The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial osteotomy for Medial Meniscus posterior root tears
Detailed description
All Patients included in this clinical trial will be informed by written consent will undergo a one week screening to determine the eligibility for study entry.
Patients who meet the eligibility requirements will be randomized in a single blinded manner (patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Repair | Active comparator | Procedure: Arthroscopic RepairArthroscopic Repair for medial meniscus posterior root tears |
| High tibial osteotomy | Active comparator | Procedure: High tibial osteotomyOpen wedge High tibial osteotomy for medial meniscus posterior root tears |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sex: both sexes.
- Age: Above 40
- Degree of Varus: Neutral to 10 degrees of Varus
Key exclusion criteria (2 listed)
- History of high energy trauma.
- Multiligamentous knee Injury.
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 RepairArthroscopic Repair for medial meniscus posterior Root tears | Procedure or surgery | Arthroscopic Repair |
| High tibial osteotomyOpen Wedge High tibial osteotomy for medial meniscus posterior Root tears | Procedure or surgery | High tibial osteotomy |
Primary outcome
Lysholm Score
Time frame: 3 month and 6 month
Validated Arabic form of Lyshlom score
IKDC Score
Time frame: 3 month and 6 month
Validated Arabic form of IKDC score
3 secondary outcomes
infection
Time frame: 3 month and 6 month
Non union
Time frame: 3 month and 6 month
Arthrofibrosis
Time frame: 3 month and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 32978022Kim KI, Bae JK, Jeon SW, Kim GB. Medial Meniscus Posterior Root Tear Does Not Affect the Outcome of Medial Open-Wedge High Tibial Osteotomy. J Arthroplasty. 2021 Feb;36(2):423-428. doi: 10.1016/j.arth.2020.08.067. Epub 2020 Sep 7.
- Background: PubMed 23369476Nha KW, Lee YS, Hwang DH, Kwon JH, Chae DJ, Park YJ, Kim JI. Second-look arthroscopic findings after open-wedge high tibia osteotomy focusing on the posterior root tears of the medial meniscus. Arthroscopy. 2013 Feb;29(2):226-31. doi: 10.1016/j.arthro.2012.08.027.
- Background: PubMed 18815238Marzo JM, Gurske-DePerio J. Effects of medial meniscus posterior horn avulsion and repair on tibiofemoral contact area and peak contact pressure with clinical implications. Am J Sports Med. 2009 Jan;37(1):124-9. doi: 10.1177/0363546508323254. Epub 2008 Sep 24.
- Background: PubMed 25979687Feucht MJ, Kuhle J, Bode G, Mehl J, Schmal H, Sudkamp NP, Niemeyer P. Arthroscopic Transtibial Pullout Repair for Posterior Medial Meniscus Root Tears: A Systematic Review of Clinical, Radiographic, and Second-Look Arthroscopic Results. Arthroscopy. 2015 Sep;31(9):1808-16. doi: 10.1016/j.arthro.2015.03.022. Epub 2015 May 13.
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Active, not recruitingObservational study
Knee Medial Collateral Ligament Recovery After Pie-Crusting Release Technique
Medial Collateral Ligament, Medial Mensical Tear
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.
Wael S. Abdel Megid, Professor study director
Ain Shams University
Zeiad M. Zakaria, Assistant Professor study director
Ain Shams University
Radwan G. Abdel Hamid, Assistant Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Repair and High tibial osteotomy in people with Medial Mensical Tear, run by Ain Shams University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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 Egypt. 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 Amr S. Ahmed, Master (+201113742474, AmrElhady@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Score (time frame: 3 month and 6 month). The study lists 2 primary outcomes in all. 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 NCT05971472, which also lists 4 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 2 Aug 2023.