Platelet Rich Plasma on Rotator Cuff Repair (PRP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Criogenesis
Information provided by (Responsible Party):
Eduardo Angeli Malavolta, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01029574
First received: December 9, 2009
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

Repair of the rotator cuff has high rates of re-rupture (20-54%), despite good clinical results. Several ways to improve the healing tendon-bone are currently studied, among them the most used is the use of growth factors. The platelet-rich plasma is a source of several growth factors, and is already used in various orthopedic procedures. The aim of this study is to evaluate the effectiveness of platelet-rich plasma in improve tendon-bone healing in arthroscopic rotator cuff repairs.


Condition Intervention Phase
Rotator Cuff Tears
Other: Platelet rich plasma
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet Rich Plasma on Arthroscopic Repair of the Complete Rotator Cuff Lesions: a Prospective and Randomized Study

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • UCLA Score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Constant Scores and Re-tear rate (MRI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotator cuff repair plus PRP
Conventional arthroscopic repair of rotator cuff with application of PRP.
Other: Platelet rich plasma
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
Placebo Comparator: Rotator cuff repair alone
Conventional arthroscopic repair of rotator cuff without application of PRP
Other: Platelet rich plasma
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.

Detailed Description:

Rotator cuff repair(RCR) is a procedure widely performed in the shoulder surgery, given the high prevalence of this type of injury in the population. Regardless of the approach employed, the procedure consists of the rehabilitation of the rotator cuff to his bed. Despite the clinical results are highly satisfactory (success rate around 85%), studies using ultrasound and magnetic resonance imaging (MRI) showed a rate of re-rupture after surgery 20 to 54%. These levels of re-injury suggest a sub-optimal healing in the bone-tendon interface.

Attempts to improve the healing in place of the RMR has been extensively studied in the orthopedic literature. One is the use of growth factors (GF), cytokines play an important role in chemotaxis, cell proliferation and differentiation, as well as the synthesis of extracellular matrix, and that theoretically could have beneficial role in tissue repair.

The Platelet-Rich Plasma (PRP) is one of the most studied sources of GF. It is easy to prepare and non-immunogenic (is done with the patient's own blood), and has the further advantage of the presence of several FC (including PDGF, bFGF, TGF-B, VEGF, EGF, CTGF and IGF). This fact is important because the disease have different effects on different receivers during the various stages of healing.

The use of PRP in bone healing has been evaluated in several studies with conflicting results. There are preclinical studies demonstrating the beneficial effect of PRP on tendon and ligament repair. However, there is no published papers showing the effectiveness of the use of PRP on tendon-bone interface.

The aim of this study is to evaluate the effectiveness of PRP in enhancing the healing tendon-bone repair after injury of RC.

Will be operated patients with complete injury (full thickness) of the rotator cuff, divided into two groups randomly. The use of PRP or not will be decided by sealed envelopes, with 20 individuals in each group. The subjects will be assessed pre and postoperatively according to the criteria for the Constant and UCLA and with the help of MRI, being unknown to the evaluators to which group the patient belongs.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain or functional deficit in the shoulder to justify surgical intervention;
  • Complete lesion(full thickness) of the supraspinatus tendon resulting from trauma or degenerative confirmed by MRI;
  • Patients skeletally mature, regardless of sex;
  • Signing the consent form.

Exclusion Criteria:

  • Psychiatric disorders;
  • Vascular-nerve lesions affecting the upper limb;
  • Pregnancy;
  • Immature skeleton;
  • Comorbidities unmatched clinically;
  • Osteoarthritis of the acromioclavicular joint symptomatic requiring surgical intervention;
  • Glenohumeral arthrosis grades 2, 3 and 4 Samilson and Prieto;
  • Rotator Cuff Arthropathy grades IB, IIA and IIB of Seebauer;
  • Active or recent infection;
  • Neuropathic arthropathy;
  • Previous surgery on the same shoulder operated;
  • Patients with painful pathologies of the cervical spine;
  • Patients diagnosed with fibromyalgia;
  • Patients who do not understand or do not agree with the consent form;
  • Fatty degeneration of the muscles of the MR resonance;
  • Retraction of the tendon greater than 3cm (MRI or intraoperative);
  • Subscapular or Infraspinatus rupture that needs repair (MRI or intraoperative).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029574

Locations
Brazil
University of São Paulo - Orthopedics and traumatology department
São Paulo, Brazil, 05403-010
University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Criogenesis
Investigators
Principal Investigator: Eduardo A Malavolta, MD University of Sao Paulo - Orthopedic and Traumatology Department
Study Director: Arnaldo A Ferreira Neto, PhD University of Sao Paulo - Orthopedic and Traumatology Department
  More Information

No publications provided

Responsible Party: Eduardo Angeli Malavolta, Dr, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01029574     History of Changes
Other Study ID Numbers: 0292/08
Study First Received: December 9, 2009
Last Updated: August 16, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Rotator cuff lesions
Platelet rich plasma
Arthroscopic repair

ClinicalTrials.gov processed this record on September 15, 2014