NCT05053646

Brief Summary

Meniscal suture represents the current surgical practice, and marrow venting is a low risk procedure. Bone venting may be able to improve the outcome of meniscal repair, allowing the patient a better recovery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
54mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Dec 2021Oct 2030

First Submitted

Initial submission to the registry

July 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

8.8 years

First QC Date

July 22, 2021

Last Update Submit

August 5, 2025

Conditions

Meniscal Tear

Outcome Measures

Primary Outcomes (1)

  • subjective International Knee Documentation Committee (IKDC) score

    evaluated subjective IKDC score 2-years after intervention in two groups

    2 years

Secondary Outcomes (11)

  • Objective International Knee Documentation Committee (IKDC)

    (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  • Lysholm score (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

    (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  • Knee Injury and Osteoarthritis Outcome Score - KOOS

    (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  • Pain 0-10 Numerical Rating Scale (NRS)

    (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  • Function 0-10 Numerical Rating Scale (NRS)

    (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)

  • +6 more secondary outcomes

Study Arms (2)

Marrow venting arm

EXPERIMENTAL

Meniscal suture associated with marrow venting procedure

Procedure: Meniscal repairProcedure: Marrow venting procedure

Control arm

ACTIVE COMPARATOR

Meniscal suture alone, without marrow venting procedure

Procedure: Meniscal repair

Interventions

Meniscal repairPROCEDURE

The meniscus is trimmed with an arthroscopic punch followed by an electric shaver to expose the margins of the tear and remove damaged tissue. Vertical sutures are made using TRUESPAN™ Meniscal Repair System (DePuy Synthes) to approximate both the femoral and tibial surfaces of the torn meniscus.

Control armMarrow venting arm
Marrow venting procedurePROCEDURE

After meniscal repair, a bone marrow venting procedure will be performed: a 45° micro-fracture awl is repeatedly penetrated through the bone of the intercondylar notch at the PCL origin until marrow elements are seen to enter the joint.

Marrow venting arm

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Arthroscopic confirmed suturable meniscal tears,
  • Monolateral meniscal tears,
  • years,
  • BMI\>18,5 and \<35 kg/m2,
  • Ability to give informed consent by signature.

You may not qualify if:

  • Bilateral meniscal tears requiring treatment,
  • Associated ligament lesions requiring treatment,
  • Associated cartilage lesions (Outerbridge \> 2),
  • Knee axis deformities requiring correction
  • Generalized ligamentous laxity,
  • Radiographic knee ostheoarthritis,
  • Other reasons for knee pain,
  • Pregnant or lactating women,
  • Serious systemic diseases such as cardiac, hepatic or renal failure, rheumatic diseases, non-compensated diabetic, psychological illnesses, central or peripheral neurological diseases, and autoimmune diseases,
  • Enrolled in another ongoing clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

RECRUITING

Clinica Ars Medica

Lugano, Switzerland

RECRUITING

Related Publications (14)

  • Ahn JH, Kwon OJ, Nam TS. Arthroscopic repair of horizontal meniscal cleavage tears with marrow-stimulating technique. Arthroscopy. 2015 Jan;31(1):92-8. doi: 10.1016/j.arthro.2014.07.029. Epub 2014 Sep 18.

    PMID: 25242513BACKGROUND

  • Briggs KK, Kocher MS, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the Lysholm knee score and Tegner activity scale for patients with meniscal injury of the knee. J Bone Joint Surg Am. 2006 Apr;88(4):698-705. doi: 10.2106/JBJS.E.00339.

    PMID: 16595458BACKGROUND

  • Bryant D, Dill J, Litchfield R, Amendola A, Giffin R, Fowler P, Kirkley A. Effectiveness of bioabsorbable arrows compared with inside-out suturing for vertical, reparable meniscal lesions: a randomized clinical trial. Am J Sports Med. 2007 Jun;35(6):889-96. doi: 10.1177/0363546506298582. Epub 2007 Mar 2.

    PMID: 17337726BACKGROUND

  • Charles HC, Kraus VB, Ainslie M, Hellio Le Graverand-Gastineau MP. Optimization of the fixed-flexion knee radiograph. Osteoarthritis Cartilage. 2007 Nov;15(11):1221-4. doi: 10.1016/j.joca.2007.05.012. Epub 2007 Oct 31.

    PMID: 17977754BACKGROUND

  • Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the IKDC score for meniscus injuries of the knee. Arthroscopy. 2007 Aug;23(8):839-44. doi: 10.1016/j.arthro.2007.02.005.

    PMID: 17681205BACKGROUND

  • de Girolamo L, Galliera E, Volpi P, Denti M, Dogliotti G, Quaglia A, Cabitza P, Corsi Romanelli MM, Randelli P. Why menisci show higher healing rate when repaired during ACL reconstruction? Growth factors release can be the explanation. Knee Surg Sports Traumatol Arthrosc. 2015 Jan;23(1):90-6. doi: 10.1007/s00167-013-2712-8. Epub 2013 Oct 22.

    PMID: 24146050BACKGROUND

  • Dean CS, Chahla J, Matheny LM, Mitchell JJ, LaPrade RF. Outcomes After Biologically Augmented Isolated Meniscal Repair With Marrow Venting Are Comparable With Those After Meniscal Repair With Concomitant Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 May;45(6):1341-1348. doi: 10.1177/0363546516686968. Epub 2017 Feb 1.

    PMID: 28298056BACKGROUND

  • Ding C, Martel-Pelletier J, Pelletier JP, Abram F, Raynauld JP, Cicuttini F, Jones G. Meniscal tear as an osteoarthritis risk factor in a largely non-osteoarthritic cohort: a cross-sectional study. J Rheumatol. 2007 Apr;34(4):776-84. Epub 2007 Mar 15.

    PMID: 17361984BACKGROUND

  • Driscoll MD, Robin BN, Horie M, Hubert ZT, Sampson HW, Jupiter DC, Tharakan B, Reeve RE. Marrow stimulation improves meniscal healing at early endpoints in a rabbit meniscal injury model. Arthroscopy. 2013 Jan;29(1):113-21. doi: 10.1016/j.arthro.2012.06.023. Epub 2012 Nov 30.

    PMID: 23200846BACKGROUND

  • Englund M, Guermazi A, Roemer FW, Aliabadi P, Yang M, Lewis CE, Torner J, Nevitt MC, Sack B, Felson DT. Meniscal tear in knees without surgery and the development of radiographic osteoarthritis among middle-aged and elderly persons: The Multicenter Osteoarthritis Study. Arthritis Rheum. 2009 Mar;60(3):831-9. doi: 10.1002/art.24383.

    PMID: 19248082BACKGROUND

  • Englund M, Roemer FW, Hayashi D, Crema MD, Guermazi A. Meniscus pathology, osteoarthritis and the treatment controversy. Nat Rev Rheumatol. 2012 May 22;8(7):412-9. doi: 10.1038/nrrheum.2012.69.

    PMID: 22614907BACKGROUND

  • Freedman KB, Nho SJ, Cole BJ. Marrow stimulating technique to augment meniscus repair. Arthroscopy. 2003 Sep;19(7):794-8. doi: 10.1016/s0749-8063(03)00695-9.

    PMID: 12966391BACKGROUND

  • Howarth WR, Brochard K, Campbell SE, Grogan BF. Effect of Microfracture on Meniscal Tear Healing in a Goat (Capra hircus) Model. Orthopedics. 2016 Mar-Apr;39(2):105-10. doi: 10.3928/01477447-20160119-04. Epub 2016 Jan 25.

    PMID: 26811956BACKGROUND

  • Kaminski R, Kulinski K, Kozar-Kaminska K, Wasko MK, Langner M, Pomianowski S. Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study. Arthroscopy. 2019 May;35(5):1500-1508.e1. doi: 10.1016/j.arthro.2018.11.056. Epub 2019 Mar 20.

    PMID: 30902532BACKGROUND

Related Links

Study Officials

  • Christian Candrian, MD

    Ente Ospedaliero Cantonale, Bellinzona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian R Candrian, MD

CONTACT

+41918117029RicercaOrtopedia.ORL@eoc.ch

Gabriela Induni-Lang

CONTACT

+41918117029Gabriela.Induni-Lang@eoc.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2021

First Posted

September 22, 2021

Study Start

December 29, 2021

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)