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Clinical Trials/NCT02520089
NCT02520089CompletedNot Applicable

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

Universidad Autonoma de Nuevo Leon2 sites in 1 country23 target enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
23
Locations
2
Primary Endpoint
Stans Scale

Study Overview

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 Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: 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.

Intervention: Platelet Rich Plasma plus bone autograft (Procedure)

Outcomes

Primary Outcomes

Stans Scale

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor
Universidad Autonoma de Nuevo Leon
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carlos A Acosta-Olivo

MD, PhD

Universidad Autonoma de Nuevo Leon

Study Sites (2)

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