Humeral Shaft Pseudoarthrosis Treated With Bone Autograft Versus Platelet Rich Plasma
Comparison of Treatment of Humeral Shaft Pseudoarthrosis Between Bone Autograft Versus Platelet Rich Plasma. Randomized, Blinded Study
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 3, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
July 30, 2018
CompletedJuly 30, 2018
October 1, 2017
1.3 years
August 3, 2015
May 8, 2017
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stans Scale
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.
9th month
Secondary Outcomes (1)
Quick Disability of Arm, Shoulder and Hand
9th months
Study Arms (2)
Bone autograft
ACTIVE COMPARATORThe 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.
platelet rich plasma plus Bone autograft
EXPERIMENTALOther 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- evolution of 3 months
- initial orthopedic management
- without mental illness
You may not qualify if:
- osteoporosis
- contralateral or ipsilateral fractures
- previous fracture in same place at least 3 month
- hematologic problems
- liver disease
- cardiac, renal or lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo León, 64480, Mexico
Related Publications (6)
Carroll EA, Schweppe M, Langfitt M, Miller AN, Halvorson JJ. Management of humeral shaft fractures. J Am Acad Orthop Surg. 2012 Jul;20(7):423-33. doi: 10.5435/JAAOS-20-07-423.
PMID: 22751161BACKGROUNDLin J, Hou SM, Hang YS. Treatment of humeral shaft delayed unions and nonunions with humeral locked nails. J Trauma. 2000 Apr;48(4):695-703. doi: 10.1097/00005373-200004000-00018.
PMID: 10780604BACKGROUNDPugh DM, McKee MD. Advances in the management of humeral nonunion. J Am Acad Orthop Surg. 2003 Jan-Feb;11(1):48-59. doi: 10.5435/00124635-200301000-00007.
PMID: 12699371BACKGROUNDCelebi L, Dogan O, Muratli HH, Yagmurlu MF, Yuksel HY, Bicimoglu A. [Treatment of humeral pseudarthroses by open reduction and internal fixation]. Acta Orthop Traumatol Turc. 2005;39(3):205-10. Turkish.
PMID: 16141726BACKGROUNDKhan SN, Cammisa FP Jr, Sandhu HS, Diwan AD, Girardi FP, Lane JM. The biology of bone grafting. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):77-86.
PMID: 15712985BACKGROUNDAhmad Z, Howard D, Brooks RA, Wardale J, Henson FM, Getgood A, Rushton N. The role of platelet rich plasma in musculoskeletal science. JRSM Short Rep. 2012 Jun;3(6):40. doi: 10.1258/shorts.2011.011148. Epub 2012 Jun 19.
PMID: 22768374BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carlos Alberto Acosta-Olivo
- Organization
- Universidad Autonoma de Nuevo Leon
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Acosta-Olivo, MD, PhD
Universidad Autonoma de Nuevo Leon
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 3, 2015
First Posted
August 11, 2015
Study Start
November 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
July 30, 2018
Results First Posted
July 30, 2018
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share