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Meniscal ExtrusionNCT07858669

Arthroscopic Capsulodesis Decreases Meniscal Extrusion at 1 Year Follow up When Combined With Transtibial Pull Out Repair of Posteromedial Root Lesion. A Prospective Randomized Study

A study testing Meniscal root repair in people with Meniscal Extrusion, run by Institut Català de Traumatologia i Medicina de l'Esport at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary objective is to compare isolated single tunnel transtibial pull out posterior medial meniscus root repair (PMMRR) with the same repair augmented by arthroscopic capsulodesis. Study design: Prospective randomized controlled trial. The study will be registered in the international Clinical Trials registry. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Meniscal Extrusion
What is being tested?
Meniscal root repair
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSpain
Study dates
21 May 2024to 25 Sep 2026
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • symptomatic isolated PMMRT confirmed by MRI, type 2 or type 4 tears according to the LaPrade classification, age between 18 and 65 years, neutral coronal alignment (mechanical axis deviation <4° varus), as confirmed on standardized full-length standing radiographs.

Who cannot join

  • previous ipsilateral meniscal or ligament surgery, body mass index (BMI) >35 kg/m², advanced osteoarthritis (Kellgren-Lawrence grade III-IV), inflammatory arthropathy, metabolic bone disease, spontaneous osteonecrosis of the knee or inability to adhere to the standardized postoperative rehabilitation protocol.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario Dexeus, Barcelona, Barcelona 08028

    Barcelona

Other trials in Spain

About this study

Primary objective is to compare isolated single tunnel transtibial pull out posterior medial meniscus root repair (PMMRR) with the same repair augmented by arthroscopic capsulodesis. Study design: Prospective randomized controlled trial. The study will be registered in the international Clinical Trials registry. Inclusion criteria: symptomatic isolated PMMRT confirmed by MRI, type 2 or type 4 tears according to the LaPrade classification, age between 18 and 65 years, neutral coronal alignment (mechanical axis deviation <4° varus), as confirmed on standardized full-length standing radiographs. Exclusion criteria: previous ipsilateral meniscal or ligament surgery, body mass index (BMI) >35 kg/m², advanced osteoarthritis (Kellgren-Lawrence grade III-IV), inflammatory arthropathy, metabolic bone disease, spontaneous osteonecrosis of the knee or inability to adhere to the standardized postoperative rehabilitation protocol. Randomization: Eligible patients will be randomized in a 1:1 ratio to either isolated posterior medial meniscus root repair group (PMMRR) or PMMRR augmented with arthroscopic capsulodesis group, performed centrally by an independent statistician using a computer-generated randomization sequence with variable block sizes of 4 to 6. Image control with MRI will be performed at 3, 6 and 12 month and evaluated by two fellowship-trained musculoskeletal radiologists blinded to treatment allocation, clinical information, and temporal sequence of scans.The primary endpoint (medial meniscal extrusion at 12 months) will be analyzed using analysis of covariance (ANCOVA), with treatment group as the fixed effect, baseline extrusion as a covariate, and study center included as a random effect to account for clustering.

Being tested
Meniscal root repair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meniscal root repairProcedure or surgery

    A dedicated tibial root repair guide will be used to create a single anatomic 3.2mm transtibial tunnel from the anterolateral tibial cortex to the native posterior root attachment site.

    Two nonabsorbable high strength No. 2 sutures will be passed through the meniscal posterior horn in a cinch-loop stitch configuration, retrieved via the tibial tunnel, and securely tied over a cortical fixation button on the anterolateral tibial cortex.

  • Meniscal root repairProcedure or surgery

    Capsulodesis will be performed immediately after root repair. A single 2.4-mm tibial tunnel drilled from the anteromedial tibial cortex in an oblique direction, exiting at the edge of the medial tibial plateau. The capsule and adjacent meniscal tissue captured using spinal needles loaded with No. 2 polydioxanone sutures in an outside-in fashion. Two fixation points established: the first at the meniscal body and the second approximately 1 cm posterior to the initial capture site. Suture exchanged. Suture limbs tied over a cortical fixation button

Study groups in NCT07858669
Study groupRoleWhat they receive
Isolated single-tunnel transtibial posterior medial meniscus root repair (PMMRR)Active comparatorNot described
Receives: Procedure: Meniscal root repair
Single tunnel transtibial pull out posterior medial meniscus root repair + CapsulodesisActive comparatorNot described
Receives: Procedure: Meniscal root repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medial Meniscal Extrusion

    Medial meniscal extrusion assessed on MRI

    Measured: 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2026
  2. Study start21 May 2024
  3. Primary completion20 Sep 2026
  4. Study completion25 Sep 2026

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07858669
Sponsor's protocol ID
2023/101-COT-DEX
Status last verified
Sep 2026
First submitted
29 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Anderson MJJ, Hollenbeck JFM, Drumm AH, Whicker EA, Brown JR, Garcia AR, Apostolakos JM, Buchalter WH, Cortes N, Whalen RJ, Vidal AF, Provencher MT. Medial Meniscotibial Ligament Deficiency Increases Medial Meniscus Extrusion and Posterior Root Forces. Am J Sports Med. 2025 Mar;53(3):666-672. doi: 10.1177/03635465241309671. Epub 2025 Jan 22.

    PubMed 39838909
  • Boksh K, E T Shepherd D, M Espino D, Ghosh A, Aujla R, Boutefnouchet T. Centralization reduces meniscal extrusion, improves joint mechanics and functional outcomes in patients undergoing meniscus surgery: A systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2025 Mar;33(3):888-906. doi: 10.1002/ksa.12410. Epub 2024 Aug 9.

    PubMed 39118448
  • Kohno Y, Koga H, Ozeki N, Matsuda J, Mizuno M, Katano H, Sekiya I. Biomechanical analysis of a centralization procedure for extruded lateral meniscus after meniscectomy in porcine knee joints. J Orthop Res. 2022 May;40(5):1097-1103. doi: 10.1002/jor.25146. Epub 2021 Aug 5.

    PubMed 34314533
  • Perry AK, Lavoie-Gagne O, Knapik DM, Maheshwer B, Hodakowski A, Gursoy S, LaPrade RF, Chahla J. Examining the Efficacy of Medial Meniscus Posterior Root Repair: A Meta-analysis and Systematic Review of Biomechanical and Clinical Outcomes. Am J Sports Med. 2023 Jun;51(7):1914-1926. doi: 10.1177/03635465221077271. Epub 2022 Apr 6.

    PubMed 35384728
  • Swamy N, Wadhwa V, Bajaj G, Chhabra A, Pandey T. Medial meniscal extrusion: Detection, evaluation and clinical implications. Eur J Radiol. 2018 May;102:115-124. doi: 10.1016/j.ejrad.2018.03.007. Epub 2018 Mar 6.

    PubMed 29685524
  • Langhans MT, Lamba A, Saris DBF, Smith P, Krych AJ. Meniscal Extrusion: Diagnosis, Etiology, and Treatment Options. Curr Rev Musculoskelet Med. 2023 Jul;16(7):316-327. doi: 10.1007/s12178-023-09840-4. Epub 2023 May 16.

    PubMed 37191818
  • Masferrer-Pino A, Monllau JC, Ibanez M, Erquicia JI, Pelfort X, Gelber PE. Capsulodesis Versus Bone Trough Technique in Lateral Meniscal Allograft Transplantation: Graft Extrusion and Functional Results. Arthroscopy. 2018 Jun;34(6):1879-1888. doi: 10.1016/j.arthro.2018.01.017. Epub 2018 Mar 21.

    PubMed 29573933
  • Cortina G, Perelli S, Pizza N, Condello V, Madonna V, Monllau JC. Medial meniscus posterior root tear repair: An overview of surgical techniques and augmentation strategies. J Exp Orthop. 2026 Jan 11;13(1):e70578. doi: 10.1002/jeo2.70578. eCollection 2026 Jan.

    PubMed 41531481
  • Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.

    PubMed 16139163
  • LaPrade CM, James EW, Cram TR, Feagin JA, Engebretsen L, LaPrade RF. Meniscal root tears: a classification system based on tear morphology. Am J Sports Med. 2015 Feb;43(2):363-9. doi: 10.1177/0363546514559684. Epub 2014 Dec 1.

    PubMed 25451789
  • Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 Statement: Updated Guideline for Reporting Randomized Trials. JAMA. 2025 Jun 10;333(22):1998-2005. doi: 10.1001/jama.2025.4347.

    PubMed 40228499
  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

    PubMed 24141714
  • Tollefson LV, Kajabi AW, Hedayati E, Knutsen K, Takahashi T, Ellermann J, LaPrade RF. Medial Meniscal Extrusion Increased on 6-Month Magnetic Resonance Imaging, Despite Successful Posterior Root Repair With or Without a Centralization Suture: A Randomized Controlled Clinical Trial. Am J Sports Med. 2025 Oct;53(12):2808-2816. doi: 10.1177/03635465251366443. Epub 2025 Sep 3.

    PubMed 40901697
  • Morales-Avalos R, Diabb-Zavala JM, Mohamed-Noriega N, Vilchez-Cavazos F, Perelli S, Padilla-Medina JR, Torres-Gaytan AG, Huesca-Perez HA, Erosa-Villarreal RA, Monllau JC. Effect of Injury to the Lateral Meniscotibial Ligament and Meniscofibular Ligament on Meniscal Extrusion: Biomechanical Evaluation of the Capsulodesis and Centralization Techniques in a Porcine Knee Model. Orthop J Sports Med. 2023 Nov 23;11(11):23259671231212856. doi: 10.1177/23259671231212856. eCollection 2023 Nov.

    PubMed 38021298
  • Monllau JC, Ibanez M, Masferrer-Pino A, Gelber PE, Erquicia JI, Pelfort X. Lateral Capsular Fixation: An Implant-Free Technique to Prevent Meniscal Allograft Extrusion. Arthrosc Tech. 2017 Mar 6;6(2):e269-e274. doi: 10.1016/j.eats.2016.09.032. eCollection 2017 Apr.

    PubMed 28580241

Questions about this trial

What is this clinical trial studying?

A study testing Meniscal root repair in people with Meniscal Extrusion, run by Institut Català de Traumatologia i Medicina de l'Esport at 1 site in Spain.

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 1 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: finished, as of the sponsor's last update on 5 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medial Meniscal Extrusion (time frame: 3, 6, and 12 months). 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 NCT07858669, which also lists 24 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 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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