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Patellar Tendon Regeneration With Platelet-rich Plasma

NCT01111747 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2012-03-14

No results posted yet for this study

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

Interventions

PROCEDURE

Platelet-rich plasma

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

PROCEDURE

Control group

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Adriano M Almeida, MD · Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil

  • Arnaldo J Hernandez, MD, PhD · Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-07-31
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01111747 on ClinicalTrials.gov