Patellar Tendon Regeneration With Platelet-rich Plasma

NCT01111747 | Completed Phase 4

• 2 other identifiers: 0162/08CaPPesqHCFMUSP 0162/2008
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Instability

Keywords

platelet-rich plasma; patellar ligament; regeneration; growth substances

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Isokinetic testing and questionaires.

  Six months

Study Arms (2)

PRP

EXPERIMENTAL

In this group PRP will be used in the patellar tendon donor site.

Procedure: Platelet-rich plasma

Control

SHAM COMPARATOR

In this group PRP will not be aded to the patellar tendon donor site

Procedure: Control group

Interventions

Platelet-rich plasma PROCEDURE

Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.

Also known as: PRP, platelet gel, platelet concentrate, growth factors concentrate, plasma rich in growth factors

PRP

Control group PROCEDURE

In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.

Also known as: PRP, platelet-rich plasma, platelet gel, platelet concentrate, growth factors concentrate, plasma rich in growth factors

Control

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• indication of anterior cruciate ligament surgery with patellar ligament
• skeletal maturity

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil: collaborator

Related Publications (10)

• 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.

  PMID: 10750999 BACKGROUND

• 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.

  PMID: 8472418 BACKGROUND

• 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.

  PMID: 14754721 BACKGROUND

• 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.

  PMID: 16055249 BACKGROUND

• 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.

  PMID: 14691563 BACKGROUND

• 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.

  PMID: 15612333 BACKGROUND

• 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.

  PMID: 12696985 BACKGROUND

• 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.

  PMID: 17583812 BACKGROUND

• 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.

  PMID: 17974893 BACKGROUND

• 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.

  PMID: 17099241 BACKGROUND

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins; Control Groups

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Adriano M Almeida, MD

  Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil

  PRINCIPAL INVESTIGATOR

• Arnaldo J Hernandez, MD, PhD

  Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 14, 2012

Record last verified: 2010-04