Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

NCT01123889

Subacromial Impingement Syndrome Partial Thickness Rotator Cuff Tear

COMPLETED NA

The Effects of Platelet-Rich Plasma Versus Prolotherapy On Rotator Cuff Tendinopathy: A Randomized Controlled Trial.

NCT04640662

Rotator Cuff Tendinosis Supraspinatus Strain PRP

COMPLETED PHASE1

"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"

NCT04041258

Pseudoarthrosis of the Clavicle

TERMINATED NA

The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear

NCT03548662

Rotator Cuff Tear

COMPLETED PHASE1

Treatment of Rotator Cuff Tears With Platelet Rich Plasma

NCT06481046

Rotator Cuff Tears Rotator Cuff Tendinitis

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pseudoarthrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bone autograft

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.

Group Type ACTIVE_COMPARATOR

bone autograft of iliac crest

Intervention Type PROCEDURE

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

platelet rich plasma plus Bone autograft

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.

Group Type EXPERIMENTAL

Platelet Rich Plasma plus bone autograft

Intervention Type PROCEDURE

Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bone autograft of iliac crest

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

Intervention Type PROCEDURE

Platelet Rich Plasma plus bone autograft

Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biomet GPS III MTF Cascade

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No