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临床试验/NCT02520089
NCT02520089已完成不适用

Comparison of Treatment of Humeral Shaft Pseudoarthrosis Between Bone Autograft Versus Platelet Rich Plasma. Randomized, Blinded Study

Universidad Autonoma de Nuevo Leon2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Stans Scale

研究概览

简要总结

Patients with humeral shaft pseudoarthrosis is going to be treated with a standard protocol with a locking compression plate and bone autograft, and other group of patients treated with platelet rich plasma.

Posteriorly all the patients it will evaluated radiographically and with functional scales for a period of one year.

详细描述

Pseudarthrosis is a condition characterized by the absence of union from 3-4 months of the start of a fracture. It usually has symptoms manifested by pain and loss of function of the affected extremity. In addition to radiographic data with lack of consolidation in the fracture. The surgical indications in patients with pseudoarthrosis data are the presence of pain and the mobility of the fracture taking account the time evolution.

The humeral shaft fracture represent 3% of the general fractures, appearing around 66,000 cases per year in the United States. The conservative treatment with a brace has been used since the 1970's. Mostly of the humeral shaft fractures are managed with this option. Contraindications are those fractures which are bilateral or in polytraumatized patients who do not have the ability to roam.

Surgical treatment seeks to provide a stable fixation providing an early mobilization. The union of these fractures occurs in a period ranging from 12 to 24 weeks. The use of a Locking Compression Plate where there must be at least six cortical fixation on both fragments is actually recommended, besides is necessary applies also bone autograft to promote ossification has osteogenic, osteoinductive, and osteoconductive properties, with an radiographic union between the nineteen weeks.

The platelet-rich plasma (PRP) is obtained from a sample of autologous blood, and after processing it have growth factors that stimulate angiogenesis and cell proliferation. It has been used since 1990 to treat jaw fracture with bone autograft and tendon injury in rotator cuff with a good evolution. It has been bone consolidation from 8 to 24 weeks.

Preparation of platelet-rich plasma A 40-ml volume of whole blood was taken from the basilic or antecubital vein of the upper limb in sterile tubes and vacuum sealed with 3.8% sodium citrate as an anticoagulant. The samples were transported to the Tissue Engineering Laboratory of the Bone and Tissue Bank where they were centrifuged for 10 minutes at 1800 rpm to separate the cellular parts corresponding to the erythrocytes and leukocytes. The upper plasma layer was removed from each of the tubes (taking care not to remove the buffy coat) and collected into a 50-ml sterile conical polypropylene tube for a second centrifugation step for 12 min at 3400 rpm. The plasma supernatant, or platelet poor plasma, was removed, leaving a volume of 3 ml in which the platelets were resuspended. The 3 ml of PRP obtained was transferred to a sterile glass tube and vacuum sealed without anticoagulant. An aliquot of the final PRP was sent to the laboratory to quantify the number of platelets. Manipulation of the samples was performed in a sterile environment within a class II biosafety cabinet. Prior to the administration of PRP to the patient, activation of the platelets was induced by adding 0.45 ml of 10% calcium gluconate and inverting the sample several times to ensure a homogeneous mixture. Then, the activated PRP was aspirated with a 5-ml syringe for application to the patient using the technique described above after asepsis and the application of 2 ml of lidocaine into the application site.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • evolution of 3 months
  • initial orthopedic management
  • without mental illness

排除标准

  • osteoporosis
  • contralateral or ipsilateral fractures
  • previous fracture in same place at least 3 month
  • hematologic problems
  • liver disease
  • cardiac, renal or lung disease

研究组 & 干预措施

Bone autograft

Active Comparator

The investigator it will obtain bone autograft of iliac crest ipsilateral of each patient. And apply into the pseudoarthrosis focus at the moment of the fixation with a locking compression plates.

干预措施: bone autograft of iliac crest (Procedure)

platelet rich plasma plus Bone autograft

Experimental

Other group of patients it will be extracted 40 mL of peripheric blood sample, and processed with a double-centrifugation technique to obtain 5 mL of platelet rich plasma, and collocated into the focus of pseudoarthrosis after standard fixation with locking compression plates and Bone Autograft of Iliac Crest.

干预措施: Platelet Rich Plasma plus bone autograft (Procedure)

结局指标

主要结局

Stans Scale

时间窗: 9th month

The evaluation of the radiographic extent of the bony callus (consolidation grade) will be assessed via anteroposterior and lateral radiograph of the arm and classified in different levels, as follows: * Grade 0, no identifiable bony callus . * Grade 1, primary bony callus formation with little or no new periosteal bone. * Grade 2, new periosteal bone formation on two sides of the humerus. * Grade 3, new periosteal bone formation on three or four sides of the humerus.

次要结局

  • Quick Disability of Arm, Shoulder and Hand(9th months)

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos A Acosta-Olivo

MD, PhD

Universidad Autonoma de Nuevo Leon

研究点 (2)

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