Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02520089
• Date of registration: 03/08/2015
• Prospective Registration: No
• Primary sponsor: Universidad Autonoma de Nuevo Leon
• Public title: Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma
• Scientific title: Comparison of Treatment of Humeral Shaft Pseudoarthrosis Between Bone Autograft Versus Platelet Rich Plasma. Randomized, Blinded Study
• Date of first enrolment: November 2014
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02520089
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Carlos Acosta-Olivo, MD, PhD
• Affiliation: Universidad Autonoma de Nuevo Leon

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pseudoarthrosis

Intervention(s)

Procedure: bone autograft of iliac crest

Procedure: Platelet Rich Plasma

Primary Outcome(s)

Radiographic consolidation [Time Frame: 6th month]

Secondary Outcome(s)

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

Secondary ID(s)

OR14-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors