Patellar Tendon Regeneration With Platelet-rich Plasma

March 13, 2012 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 concentrate
  • platelet gel
  • 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 concentrate
  • platelet gel
  • growth factors concentrate
  • plasma rich in growth factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the patellar tendon regeneration with magnetic resonance imaging.
Time Frame: Six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isokinetic testing and questionaires.
Time Frame: Six months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0162/08
  • CaPPesqHCFMUSP 0162/2008 (Other Identifier: São Paulo University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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