Study Results
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Basic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2008-11-30
2010-12-31
Brief Summary
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The platelets are obtained from the patient's blood through a filtration system called apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.
The patients are randomized in two groups, one with the use of PRP and the other group without PRP. This information for the patients will be granted just at the end of the research. After the surgery the rehabilitation protocol is the same for both groups. An isokinetic testing is done before the surgery and after six months. Questionnaires about the knee function are asked before the surgery and after six months. A magnetic resonance imaging is performed after six months to evaluate the tendon regeneration.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PRP
In this group PRP will be used in the patellar tendon donor site.
Platelet-rich plasma
Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.
Control
In this group PRP will not be aded to the patellar tendon donor site
Control group
In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.
Interventions
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Platelet-rich plasma
Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.
Control group
In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* skeletal maturity
Exclusion Criteria
* severe chondral lesions
* osteoarthritis
* non-compliance to the rehabilitation
* previous surgery in the affected knee
* reoperation during the time of the study for an unrelated condition
* infection
45 Years
ALL
No
Sponsors
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Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
UNKNOWN
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Adriano M Almeida, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
Arnaldo J Hernandez, MD, PhD
Role: STUDY_DIRECTOR
Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
References
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Kartus J, Movin T, Papadogiannakis N, Christensen LR, Lindahl S, Karlsson J. A radiographic and histologic evaluation of the patellar tendon after harvesting its central third. Am J Sports Med. 2000 Mar-Apr;28(2):218-26. doi: 10.1177/03635465000280021301.
Meisterling RC, Wadsworth T, Ardill R, Griffiths H, Lane-Larsen CL. Morphologic changes in the human patellar tendon after bone-tendon-bone anterior cruciate ligament reconstruction. Clin Orthop Relat Res. 1993 Apr;(289):208-12.
Svensson M, Kartus J, Ejerhed L, Lindahl S, Karlsson J. Does the patellar tendon normalize after harvesting its central third?: a prospective long-term MRI study. Am J Sports Med. 2004 Jan-Feb;32(1):34-8. doi: 10.1177/0363546503258935.
Anaguchi Y, Yasuda K, Majima T, Tohyama H, Minami A, Hayashi K. The effect of transforming growth factor-beta on mechanical properties of the fibrous tissue regenerated in the patellar tendon after resecting the central portion. Clin Biomech (Bristol). 2005 Nov;20(9):959-65. doi: 10.1016/j.clinbiomech.2005.05.012.
Anitua E, Andia I, Ardanza B, Nurden P, Nurden AT. Autologous platelets as a source of proteins for healing and tissue regeneration. Thromb Haemost. 2004 Jan;91(1):4-15. doi: 10.1160/TH03-07-0440.
Spindler KP, Nanney LB, Davidson JM. Proliferative responses to platelet-derived growth factor in young and old rat patellar tendon. Connect Tissue Res. 1995;31(2):171-7. doi: 10.3109/03008209509028405.
Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
Aspenberg P. Stimulation of tendon repair: mechanical loading, GDFs and platelets. A mini-review. Int Orthop. 2007 Dec;31(6):783-9. doi: 10.1007/s00264-007-0398-6. Epub 2007 Jun 22.
Rodeo SA, Potter HG, Kawamura S, Turner AS, Kim HJ, Atkinson BL. Biologic augmentation of rotator cuff tendon-healing with use of a mixture of osteoinductive growth factors. J Bone Joint Surg Am. 2007 Nov;89(11):2485-97. doi: 10.2106/JBJS.C.01627.
Sanchez M, Anitua E, Azofra J, Andia I, Padilla S, Mujika I. Comparison of surgically repaired Achilles tendon tears using platelet-rich fibrin matrices. Am J Sports Med. 2007 Feb;35(2):245-51. doi: 10.1177/0363546506294078. Epub 2006 Nov 12.
Other Identifiers
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CaPPesqHCFMUSP 0162/2008
Identifier Type: OTHER
Identifier Source: secondary_id
0162/08
Identifier Type: -
Identifier Source: org_study_id
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