Patellar Tendon Regeneration With Platelet-rich Plasma

This study has been completed.
Sponsor:
Collaborator:
Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01111747
First received: April 26, 2010
Last updated: March 13, 2012
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Knee Instability
Procedure: Platelet-rich plasma
Procedure: Control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regeneration of the Patellar Tendon After Harvesting Its Central Third With Platelet-rich Plasma. Prospective and Randomized Study.

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Evaluation of the patellar tendon regeneration with magnetic resonance imaging. [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Isokinetic testing and questionaires. [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRP
In this group PRP will be used in the patellar tendon donor site.
Procedure: Platelet-rich plasma
Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.
Other Names:
  • PRP
  • platelet-rich plasma
  • platelet gel
  • platelet concentrate
  • growth factors concentrate
  • plasma rich in growth factors
Sham Comparator: Control
In this group PRP will not be aded to the patellar tendon donor site
Procedure: Control group
In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.
Other Names:
  • PRP
  • platelet-rich plasma
  • platelet gel
  • platelet concentrate
  • growth factors concentrate
  • plasma rich in growth factors

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111747

Sponsors and Collaborators
University of Sao Paulo General Hospital
Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
Investigators
Principal Investigator: Adriano M Almeida, MD Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
Study Director: Arnaldo J Hernandez, MD, PhD Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
  More Information

Publications:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01111747     History of Changes
Other Study ID Numbers: 0162/08, CaPPesqHCFMUSP 0162/2008
Study First Received: April 26, 2010
Last Updated: March 13, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo General Hospital:
platelet-rich plasma
patellar ligament
regeneration
growth substances

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014