Pseudoarthrosis Clinical Trial
Official title:
Comparison of Treatment of Humeral Shaft Pseudoarthrosis Between Bone Autograft Versus Platelet Rich Plasma. Randomized, Blinded Study
NCT number | NCT02520089 |
Other study ID # | OR14-010 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | February 2016 |
Verified date | October 2017 |
Source | Universidad Autonoma de Nuevo Leon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad Autonoma de Nuevo Leon | Monterrey | Nuevo Leon |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Nuevo Leon |
Mexico,
Ahmad 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. — View Citation
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. Review. — View Citation
Celebi L, Dogan O, Muratli HH, Yagmurlu MF, Yüksel HY, Biçimoglu A. [Treatment of humeral pseudarthroses by open reduction and internal fixation]. Acta Orthop Traumatol Turc. 2005;39(3):205-10. Turkish. — View Citation
Khan 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. Review. — View Citation
Lin 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. — View Citation
Pugh DM, McKee MD. Advances in the management of humeral nonunion. J Am Acad Orthop Surg. 2003 Jan-Feb;11(1):48-59. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quick Disability of Arm, Shoulder and Hand | It is designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Where the better evaluation is equal to 0, and the worst evaluation is equal to 100. | 9th months |
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