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临床试验/NCT04737590
NCT04737590Unknown不适用

A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS

Turku University Hospital5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年9月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
5
主要终点
Recurrence size

研究概览

简要总结

The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.

详细描述

Twenty patients will be randomized into each group. In all University Hospitals the treatment protocol will be same. Randomization will be performed using a sealed envelope technique.

Before surgery all patients will be examined clinically. After conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures.

If the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively.

Surgical technique:

Surgery will be done by experienced paediatric orthopaedic surgeons. Normal orthopaedic exposures will be used. The cyst is opened so that square window is done to the cortex. A sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. A mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. The tumour is resected as thoroughly as possible. After curettage 5% phenol is inserted to the cavity and it is neutralized with saline. Cyst volume is evaluated using saline (ml). Then the cyst is filled with morsellized femoral head allograft or bioactive glass (BG-S53P4) according to randomization. The biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. If the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. If the cyst is in hand region then the granule size is 0,5-0,8mm. At the end of the operation the window's roof is inserted back. All the time X-ray is used to ensure that the whole cyst is treated properly. Osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture.

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
None

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Suspected aneurysmatic bone cyst in all areas, not spinal.
  • Other large simple bone cyst in load bearing areas
  • Simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas

排除标准

  • Bone marrow disease
  • Other than aneurysmatic or simple bone cyst
  • A secondary aneurysmal bone cyst (ABC associated with another underlying lesion)

结局指标

主要结局

Recurrence size

时间窗: through study completion, average 2 years

The size of cyst recurrence

Operation time

时间窗: during the surgery

Time from the cut to the closure

Hospital Stay

时间窗: immediately after the surgery

Number of days spent at the hospital

Complication

时间窗: through study completion, average 2 years

Complications during follow-up

Function (Musculoskeletal society tumor score)

时间窗: through study completion, average 2 years

Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)

Fracture after operation

时间窗: through study completion, average 2 years

Fracture after operation at the filled area in radiograph (yes / no)

Blood loss

时间窗: during the surgery

Operation's blood loss

Recurrence rate

时间窗: through study completion, average 2 years

Cyst's recurrence

Cyst-healing grade (Enneking's grading system)

时间窗: through study completion, average 2 years

Enneking's grading system (scale 1-3, 1=latent, 2=active, 3=aggressive)

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (5)

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