Knee Osteotomy Associated With Allograft Meniscus Transplantation

Официальное название

Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation

Обзор

This is a prospective randomized double-blind controlled clinical trial with parallel arms and 1:1 allocation. The main objective of the BIOMAT project is to demonstrate, through an RCT, whether the combined approach by knee osteotomy and MAT can provide clinical improvement over knee osteotomy alone for the treatment of patients with monocompartmental knee OA associated with meniscal insufficiency and lower extremity malalignment. Secondary objectives are to demonstrate whether the addition of MAT to knee osteotomy in patients with monocompartmental OA can improve biomechanical parameters and whether this treatment has protective effects on the joint environment and cartilage degeneration.

Подробное описание

Patients with single-compartment arthritic pathology of the knee, axial deviation and meniscal deficit, for whom a surgical indication of corrective osteotomy is placed, will be recruited into the study.

Enrollment takes place during hospitalization and is by the physician. All patients will undergo a knee osteotomy to achieve proper alignment of the lower limb and an arthroscopic procedure to macroscopically verify the status of the cartilage and menisci, with associated minor procedures for surgical cleanup when necessary. After intraoperative confirmation of inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment) all patients will undergo synovial biopsy and synovial fluid sampling, half of the patients will also undergo arthroscopic homologous meniscus transplantation.

Clinical, biomechanical and biological evaluations will be performed:

Clinical evaluation of the patient will be done through validated questionnaires before surgery and at 1-3-6-12 months. These will document subjective clinical improvement, functional measurements, and imaging using radiographs as per clinical practice and MRI.

Pitch Analysis will be used for biomechanical assessments, and will be performed before surgery and at 12-month follow-up after surgery for all patients enrolled in the two groups.

basal inflammation will be assessed on synovial tissue and synovial fluid samples collected after intraoperative confirmation of patient inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment). Serum/plasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up.

Вмешательства

• Процедура Knee osteotomy associated with meniscal allograft transplantation
  Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.
• Процедура Knee osteotomy
  Knee osteotomy

Первичные конечные точки

• IKDC-Subjective Score (Subjective International Knee Documentation Committee) [Срок оценки: 12 months follow-up]

Вторичные конечные точки (11)

• IKDC-Subjective Score (Subjective International Knee Documentation Committee) [Срок оценки: baseline, 1 month, 3 months and 6months follow-up]
• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score [Срок оценки: baseline, 1 month, 3 months, 6 months and 12 months follow-up]
• KOOS Score ( Knee Injury and Osteoarthritis Outcome score) [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• VAS-dolore (Visual Analogue Scale) [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• EQ-VAS [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Tegner Activity Level Scale [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• Final treatment opinion [Срок оценки: 6 and 12 months follow-up]
• WORMS (Whole-Organ Magnetic Resonance Imaging Score) [Срок оценки: baseline, 12 months follow-up]
• Kellgren-Lawrence score [Срок оценки: baseline, 1 month, 6 months, 12 months follow-up.]
• Biomechanical analysis [Срок оценки: baseline, 12 months follow-up]
• Biological assessments [Срок оценки: Baseline (pre-operative), 24 hours, 1 month, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• Male or female patients aged between 20 and 60 years;
• Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
• Surgical indication of corrective osteotomy (axial deviation of lower extremities > 5°);
• Meniscal deficit of the compartment affected by the overload due to malalignment;
• Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
• Signature of informed consent

Критерии исключения

• Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;
• Diagnosis of neoplastic diseases;
• Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;
• Patients with uncontrolled diabetes mellitus;
• Patients with uncontrolled thyroid metabolic disorders;
• Patients abusing alcoholic beverages, drugs or medications;
• Body Mass Index > 40;
• Pregnancy or lactation status or intention to become pregnant during the period of study participation;
• Patients undergoing knee surgery in the previous 12 months.

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

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• Nicolini AP, Christiano ES, Abdalla RJ, Cohen M, de Carvalho RT. Return to Sports After High Tibial Osteotomy Using the Opening Wedge Technique. Rev Bras Ortop (Sao Paulo). 2021 Jun;56(3):313-319. doi: 10.1055/s-0040-1715514. Epub 2020 Sep 25. PMID 34239195
• McClure PK, Herzenberg JE. The Natural History of Lower Extremity Malalignment. J Pediatr Orthop. 2019 Jul;39(Issue 6, Supplement 1 Suppl 1):S14-S19. doi: 10.1097/BPO.0000000000001361. PMID 31169641
• Smoak JB, Matthews JR, Vinod AV, Kluczynski MA, Bisson LJ. An Up-to-Date Review of the Meniscus Literature: A Systematic Summary of Systematic Reviews and Meta-analyses. Orthop J Sports Med. 2020 Sep 9;8(9):2325967120950306. doi: 10.1177/2325967120950306. eCollection 2020 Sep. PMID 32953923
• Liu JN, Agarwalla A, Gomoll AH. High Tibial Osteotomy and Medial Meniscus Transplant. Clin Sports Med. 2019 Jul;38(3):401-416. doi: 10.1016/j.csm.2019.02.006. PMID 31079771
• Wang K, Sun H, Zhang K, Li S, Wu G, Zhou J, Sun X. Better outcomes are associated with cementless fixation in primary total knee arthroplasty in young patients: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Jan;99(3):e18750. doi: 10.1097/MD.0000000000018750. PMID 32011458
• Sheng P, Lehto M, Kataja M, Halonen P, Moilanen T, Pajamaki J. Patient outcome following revision total knee arthroplasty: a meta-analysis. Int Orthop. 2004 Apr;28(2):78-81. doi: 10.1007/s00264-003-0526-x. Epub 2003 Nov 20. PMID 15224164
• Huizinga MR, Gorter J, Demmer A, Bierma-Zeinstra SMA, Brouwer RW. Progression of medial compartmental osteoarthritis 2-8 years after lateral closing-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12):3679-3686. doi: 10.1007/s00167-016-4232-9. Epub 2016 Jul 7. PMID 27387307
• Ekhtiari S, Haldane CE, de Sa D, Simunovic N, Musahl V, Ayeni OR. Return to Work and Sport Following High Tibial Osteotomy: A Systematic Review. J Bone Joint Surg Am. 2016 Sep 21;98(18):1568-77. doi: 10.2106/JBJS.16.00036. PMID 27655985

Идентификаторы

NCT: NCT05840887 · BIOMAT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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