Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- International Knee Documentation Committee
研究概览
简要总结
Objective
- To evaluate the technique of percutaneous grafting with bone substitute in the knee as to its applicability and technical feasibility.
- Evaluate the results regarding functional improvement and prevention of the evolution of joint cartilage degeneration.
Material and methods Twenty patients from the Knee Group clinic who meet the criteria will be selected.
Magnetic resonance imaging will be analyzed on the PACS server. Through the resonance will be performed evaluation of the size of the bone edema in volume and its proportion in relation to the size of the affected condyle or tibial plateau and the cartilage of the femoro-tibial joint. The lesions will then be mapped in the coronal and sagittal plane.
Radiographs will be taken in antero-posterior, profile, Rosenberg knee and lower limb views.
Evaluation of the patients will be performed by the visual analog pain scale and by the KOOS, IKDC and SF-36v1 indices.
Description of Surgical Technique After the mapping the patient will be submitted to the procedure. The procedure consists in the application of a bone substitute based on injectable calcium phosphate in the area of bone edema previously mapped with the aid of radioscopy to guide. After confirming the proper positioning of the guidewire, a trephine is introduced through which the product will be injected. GRAFTYS HBS® (Graftys, Aix en Provence, France) will be used.
The procedures will be performed in a surgical center, with conventional antisepsis and asepsis techniques and under spinal anesthesia. The patient will be hospitalized and must be discharged on the first postoperative day. After the procedure the patients will be under partial load as tolerated for two weeks with free range of motion and will start physiotherapy after 2 weeks of the procedure. During hospitalization the patient will receive analgesia with intravenous Dipirone 1g every 6 hours associated with Tramadol 100mg intravenously every 8 hours if severe pain. After discharge the patient will receive analgesia with dipyrone 1g orally every 6 hours associated with Tramadol 100mg orally every 8 hours if severe pain, and Tramadol used by the patient was quantified.
Patients will then be re-evaluated at 1, 3, 12, 24 and 48 weeks with the same previous criteria and at 12 months new MRI with the same previous protocol will be performed.
详细描述
Initial assessment
All the patients included in the study were submitted to the initial evaluation, in which the following exams and scales were performed:
- Magnetic resonance of the affected knee, according to IOTHCFMUSP standard radiology protocol;
- Panoramic radiography of lower limbs to measure limb alignment;
- X-ray in antero-posterior incidence with load and knee profile;
- Functional ranges of subjective IKDC, KOOS and SF-36v1;
- Analog visual pain scale.
Radiographic evaluation and magnetic resonance imaging
The radiographs were evaluated and classified by a specialist radiologist in musculoskeletal, according to the Kellgren-Lawrence classification. The radiographs were not identified as to the moment of accomplishment, before or after the procedure. However, in many cases it was possible to identify signs of the procedure in the image, making the evaluator blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 85 years
- •Gender: both genders
- •Knee pain for at least 6 months
- •Hypercaption lesion in subchondral region of tibial plateau or femoral condyle in T2-weighted magnetic resonance imaging with fat suppression.
排除标准
- •Rheumatologic diseases diagnosed in treatment
- •Renal insufficiency requiring hemodialysis
- •Not ambulatory
- •Knee osteoarthrosis with Kellegren / Lawrence classification greater than 3
- •Alignment in varus or valgus greater than 8 degrees in relation to the mechanical axis
- •Radiographic changes in the femoro-patellar joint associated with symptoms of anterior knee pain
研究组 & 干预措施
Surgery
Group evaluated with MRI and submitted to the percutaneous introduction of cannula for bone grafting
干预措施: Percutaneous introduction of cannula (Device)
Surgery
Group evaluated with MRI and submitted to the percutaneous introduction of cannula for bone grafting
干预措施: Magnetic resonance imaging (Diagnostic Test)
Surgery
Group evaluated with MRI and submitted to the percutaneous introduction of cannula for bone grafting
干预措施: Bone Grafting (Biological)
结局指标
主要结局
International Knee Documentation Committee
时间窗: 48 weeks postoperative
knee-specific patient-reported outcome measure, comparative with pre-optative evaluation
Short Form 36 Health Survey
时间窗: 48 weeks postoperative
Patient-reported survey of patient health, comparative with pre-optative evaluation
Knee injury and Osteoarthritis Outcome Score
时间窗: 48 weeks postoperative
Evatualion of Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life, comparative with pre-optative evaluation
Visual analog scale for Pain
时间窗: 48 weeks postoperative
Unidimensional measure of pain intensity, comparative with pre-optative evaluation
次要结局
- Edema Volume evaluation(1 year postoperative)