This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing

Meniscal Tear Clinical Trial

Official title:

Biological Augmentation Of Meniscal Repair With Marrow Venting: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053646
• Other study ID #: ORL-ORT-019
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2021
• Est. completion date: October 1, 2030

Study information

• Verified date: December 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Christian R Candrian, MD
• Phone: +41918117029
• Email: RicercaOrtopedia.ORL[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Meniscal tears are one of the most common lesions of the knee and are a risk factor for the development of knee osteoarthritis. A meniscal tear commonly causes knee pain, stiffness, loss of function and sometimes catching or locking of the knee, affecting patients' ability to participate in their everyday activities. In case of ineffective conservative management, meniscal tears are treated with meniscectomy (partial or total) or meniscal repair, with the latter considered, when possible, the optimal choice. Meniscal repair consists of a suture that juxtaposes the flaps of the injured meniscus to facilitate the healing of the tear. Unfortunately, meniscal healing capability is limited. A higher rate of meniscal tears healing has been documented in patients treated simultaneously with a meniscal repair and anterior cruciate ligament reconstruction. A surgical augmentation technique performing micro-fractures on the medial aspect of the lateral femoral condyle during meniscal repair surgery has been developed to mimic the beneficial effect of anterior cruciate ligament reconstruction on the joint environment. This technique has been successfully tested in preclinical studies, in human cohort studies and, recently, in a randomized control trial. However, these randomised controlled trials present some methodological weaknesses, such as a low number of included patients, and included only full-thickness vertical longitudinal tears in the red-red zone, the meniscal tears with the highest healing potential. The effect of additional micro-fractures on the healing capacity of meniscal tears involving the red-white zone has never been tested.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2030
• Est. primary completion date: October 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Arthroscopic confirmed suturable meniscal tears,
• Monolateral meniscal tears,
• 18-45 years,
• BMI>18,5 and <35 kg/m2,
• Ability to give informed consent by signature.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Meniscal Tear

Intervention

Procedure:
• Meniscal repair
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.
• Marrow venting procedure
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.

Locations

Country	Name	City	State
Switzerland	Clinica Ars Medica	Lugano
Switzerland	Ente Ospedaliero Cantonale	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Christian Candrian

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective International Knee Documentation Committee (IKDC) score	evaluated subjective IKDC score 2-years after intervention in two groups	2 years
Secondary	Objective International Knee Documentation Committee (IKDC)	Objective IKDC - International Knee Documentation Committee (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)
Secondary	Lysholm score (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)
Secondary	Knee Injury and Osteoarthritis Outcome Score - KOOS	Knee Injury and Osteoarthritis Outcome Score - KOOS (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)
Secondary	Pain 0-10 Numerical Rating Scale (NRS)	Pain 0-10 numerical rating scale - NRS (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)
Secondary	Function 0-10 Numerical Rating Scale (NRS)	Function 0-10 numerical rating scale - NRS (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)
Secondary	Tegner score	Tegner score (prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)	(prior to the injury (e.g. referred to the day before), pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)
Secondary	Healing rate	Healing rate (MRI at 1 year)	1 year
Secondary	Treatment related adverse events	Treatment related adverse events: overall, intra-operative, short- (<3 months), mid- (3 months, 2 years), long-term (>2 years) adverse events	5 years
Secondary	Function curves during the first 6 weeks.	Function curves during the first 6 weeks.	6 weeks
Secondary	Pain curves during the first 6 weeks.	Pain curves during the first 6 weeks as retrieved by the values produced with the EOC EMApp.	6 weeks
Secondary	Radiographic progression of knee osteoarthritis	Radiographic progression of knee osteoarthritis (x-ray at 5 years)	5 years

External Links

•   7. Ordinance on Clinical Trials in Human Research (ClinO)
•   Common Terminology Criteria for Adverse Events (CTCAE)