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