Patellar Tendon Regeneration With Platelet-rich Plasma

Phase 4

Completed

• Conditions: Knee Instability
• Interventions: Procedure: Platelet-rich plasma; Procedure: Control group

• Registration Number: NCT01111747
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Status Verified: 2010-04
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-28
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP	Platelet-rich plasma	In this group PRP will be used in the patellar tendon donor site.
Control	Control group	In this group PRP will not be aded to the patellar tendon donor site

Primary Outcome Measures

Name	Time	Method
Evaluation of the patellar tendon regeneration with magnetic resonance imaging.	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 Outcome Measures

Name	Time	Method
Isokinetic testing and questionaires.	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.