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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• subjective International Knee Documentation Committee (IKDC) score [Срок оценки: 2 years]

Вторичные конечные точки (11)

• Objective International Knee Documentation Committee (IKDC) [Срок оценки: (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) [Срок оценки: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)]
• Knee Injury and Osteoarthritis Outcome Score - KOOS [Срок оценки: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)]
• Pain 0-10 Numerical Rating Scale (NRS) [Срок оценки: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)]
• Function 0-10 Numerical Rating Scale (NRS) [Срок оценки: (pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years)]
• Tegner score [Срок оценки: (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)]
• Healing rate [Срок оценки: 1 year]
• Treatment related adverse events [Срок оценки: 5 years]
• Function curves during the first 6 weeks. [Срок оценки: 6 weeks]
• Pain curves during the first 6 weeks. [Срок оценки: 6 weeks]
• Radiographic progression of knee osteoarthritis [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

• Ente Ospedaliero Cantonale — Lugano
• Clinica Ars Medica — Lugano

Публикации

• 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 25242513
• 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 16595458
• 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 17337726
• 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 17977754
• 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 17681205
• 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 24146050
• 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 28298056
• 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 17361984

Идентификаторы

NCT: NCT05053646 · ORL-ORT-019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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