Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- IKDC-Subjective Score (Subjective International Knee Documentation Committee)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Clinical evaluations will be carried out by medical personnel not involved in treatment to ensure double-blinding
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
时间窗: 12 months follow-up
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function
次要结局
- IKDC-Subjective Score (Subjective International Knee Documentation Committee)(baseline, 1 month, 3 months and 6months follow-up)
- Kellgren-Lawrence score(baseline, 1 month, 6 months, 12 months follow-up.)
- Biomechanical analysis(baseline, 12 months follow-up)
- Biological assessments(Baseline (pre-operative), 24 hours, 1 month, 3 months, 6 months, 12 months)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score(baseline, 1 month, 3 months, 6 months and 12 months follow-up)
- KOOS Score ( Knee Injury and Osteoarthritis Outcome score)(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Tegner Activity Level Scale(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- WORMS (Whole-Organ Magnetic Resonance Imaging Score)(baseline, 12 months follow-up)
- EQ-VAS(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- Final treatment opinion(6 and 12 months follow-up)
- VAS-dolore (Visual Analogue Scale)(baseline, 1 month, 3 months, 6 and 12 months follow-up)