Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma
Condition: Pseudoarthrosis
MeSH terms: Pseudarthrosis
Study type: Interventional

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.

      The patient must sign the format of informed consent to the authorization of the surgery and
      the use of platelet-rich plasma.

      After signing informed consent, will divide the patients in two randomized groups to make the
      comparative and longitudinal study. A control group of patients who will receive treatment
      with surgery on the basis of open reduction with locking compression plate and autologous
      bone of iliac crest. The experimental group of patients will receive the above-mentioned
      treatment more the application of plasma rich platelets at the level of the fracture focus.

      After the surgery all the patients will be assessed at outpatient at 10 days for evaluation,
      pendulum exercises and the first radiographic evaluation. The patient will be attending
      consultation to continue his post-surgical evolution. During the follow-up visits, the
      radiographic extent of the bony callus was assessed 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. The follow-up is for one year.

      Sample size calculation Using a formula to test hypothesis and two mean difference, with a
      value of zα of 1.96 with significance level of 95 for two tails, and a value zβ of 0.84 with
      an output of 80, a sample was obtained of 7 participants per group, whereas an average of 19
      weeks for group control with a standard deviation of 3 hoping to reduce up to 4 weeks the
      start of consolidation with the application of PRP.
    

Intervention name(s): bone autograft of iliac crest; Platelet Rich Plasma plus bone autograft
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties; Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis
Other intervention name(s): Biomet GPS III; MTF Cascade
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: platelet-rich plasma; bone grafting; pseudoarthrosis