Patellar Tendon Regeneration With Platelet-rich Plasma

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Instability

Intervention / Treatment
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* Procedure: Platelet-rich plasma
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>In this group PRP will be used in the patellar tendon donor site. | Procedure: Platelet-rich plasma<br>* Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.<br>* Other names: plasma rich in growth factors;|
| Sham Comparator: Control<br>In this group PRP will not be aded to the patellar tendon donor site | Procedure: Control group<br>* In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.<br>* Other names: plasma rich in growth factors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the patellar tendon regeneration with magnetic resonance imaging. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet-rich plasma, patellar ligament, regeneration, growth substances