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Completed

NCT Number: NCT01111747

Patellar Tendon Regeneration With Platelet-rich Plasma

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.

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Key information

Conditions

Age range

Up to 45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet-rich plasma

Procedure

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

Other names: PRP, platelet gel, platelet concentrate, growth factors concentrate, plasma rich in growth factors

Control Group

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 28, 2010
Registry last updated
Mar 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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