Patellar Tendon Regeneration With Platelet-rich Plasma

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Knee Instability

Treatments: Procedure: Control group; Procedure: Platelet-rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT01111747

0162/08

CaPPesqHCFMUSP 0162/2008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: Under 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

PRP

Experimental group

Description:

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

Treatment:

Procedure: Platelet-rich plasma

Control

Sham Comparator group

Description:

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

Treatment:

Procedure: Control group