Patellar Tendon Regeneration With Platelet-rich Plasma

Knee Instability Clinical Trial

Official title:

Regeneration of the Patellar Tendon After Harvesting Its Central Third With Platelet-rich Plasma. Prospective and Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111747
• Other study ID #: 0162/08
• Secondary ID: CaPPesqHCFMUSP 0
• Status: Completed
• Phase: Phase 4
• First received: April 26, 2010
• Last updated: March 13, 2012
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The central third of the patellar tendon is used as a donor site for anterior cruciate ligament (ACL) reconstruction. After months or years the harvest site partially regenerates. The regeneration process is accomplished by biological mechanisms,including cells and proteins known as growth factors. The platelets are natural reservoirs of growth factors, and a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase in growth factors. The hypothesis of the study is that the PRP can improve the regeneration of the patellar tendon.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 45 Years

Eligibility

Inclusion Criteria:

• indication of anterior cruciate ligament surgery with patellar ligament

• skeletal maturity

Exclusion Criteria:

• other knee ligament injuries

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Instability

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil

References & Publications (10)

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, Avon). 2005 Nov;20(9):959-65. — View Citation

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. Review. — View Citation

Aspenberg P. Stimulation of tendon repair: mechanical loading, GDFs and platelets. A mini-review. Int Orthop. 2007 Dec;31(6):783-9. Epub 2007 Jun 22. — View Citation

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. — View Citation

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. — View Citation

Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. Review. — View Citation

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. — View Citation

Sánchez M, Anitua E, Azofra J, Andía 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. Epub 2006 Nov 12. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the patellar tendon regeneration with magnetic resonance imaging.	Six months after the surgery a magnetic resonance imaging will be done to evaluate the regeneration of the patellar tendon donor site. The area of the gap, related to the tendon harvest, will be measured and compared between the groups.	Six months	No
Secondary	Isokinetic testing and questionaires.	Six months after the surgery, patients will answer to questionaires about their knee function and do an isokinetic testing to evaluate their muscle strength. The results will be compared between the groups.	Six months	No