Clinical Trial: Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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
Sponsor: Universidad Autonoma de Nuevo Leon

Current Primary Outcome: Radiographic consolidation [ Time Frame: 6th month ]

The evaluation of the radiographic extent of the bony callus it will be via anteroposterior and lateral radiograph of the arm 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,; and grade 3, new periosteal bone formation on three or four sides of the humerus.


Original Primary Outcome: Same as current

Current Secondary Outcome: Quick Disability of Arm, Shoulder and Hand [ Time Frame: 6th mont ]

It is designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Where the better evaluation is equal to 0, and the worst evaluation is equal to 100.


Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de Nuevo Leon

Dates:
Date Received: August 3, 2015
Date Started: November 2014
Date Completion:
Last Updated: March 29, 2016
Last Verified: January 2016