Clinical trial NCT01111747: Patellar Tendon Regeneration With Platelet-rich Plasma
Official title: Regeneration of the Patellar Tendon After Harvesting Its Central Third With Platelet-rich Plasma. Prospective and Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Instability
Keywords: platelet-rich plasma
patellar ligament
regeneration
growth substances
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
First posted: 2010-04-28
Enrollment: 27
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the patellar tendon regeneration with magnetic resonance imaging.
timeFrame: Six months
Secondary outcomes:
measure: Isokinetic testing and questionaires.
timeFrame: Six months
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
name: Adriano M Almeida, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Ortopedia e Traumatologia - HCFMUSP - São Paulo, Brazil
name: Arnaldo J Hernandez, MD, PhD
role: STUDY_DIRECTOR
References:
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