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Platelet Rich Plasma on Rotator Cuff Repair (PRP)

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Rotator cuff lesions, Platelet rich plasma, Arthroscopic repair

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of São Paulo - Orthopedics and traumatology department
  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rotator cuff repair plus PRP

Rotator cuff repair alone

Arm Description

Conventional arthroscopic repair of rotator cuff with application of PRP.

Conventional arthroscopic repair of rotator cuff without application of PRP

Outcomes

Primary Outcome Measures

UCLA Score

Secondary Outcome Measures

Constant Scores and Re-tear rate (MRI)

Full Information

First Posted
December 9, 2009
Last Updated
December 2, 2014
Sponsor
University of Sao Paulo
Collaborators
Criogenesis
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1. Study Identification

Unique Protocol Identification Number
NCT01029574
Brief Title
Platelet Rich Plasma on Rotator Cuff Repair
Acronym
PRP
Official Title
Platelet Rich Plasma on Arthroscopic Repair of the Complete Rotator Cuff Lesions: a Prospective and Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Criogenesis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Rotator cuff lesions, Platelet rich plasma, Arthroscopic repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotator cuff repair plus PRP
Arm Type
Experimental
Arm Description
Conventional arthroscopic repair of rotator cuff with application of PRP.
Arm Title
Rotator cuff repair alone
Arm Type
Placebo Comparator
Arm Description
Conventional arthroscopic repair of rotator cuff without application of PRP
Intervention Type
Other
Intervention Name(s)
Platelet rich plasma
Intervention Description
Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.
Primary Outcome Measure Information:
Title
UCLA Score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Constant Scores and Re-tear rate (MRI)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo A Malavolta, MD
Organizational Affiliation
University of Sao Paulo - Orthopedic and Traumatology Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnaldo A Ferreira Neto, PhD
Organizational Affiliation
University of Sao Paulo - Orthopedic and Traumatology Department
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo - Orthopedics and traumatology department
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
University of São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30234999
Citation
Malavolta EA, Gracitelli MEC, Assuncao JH, Ferreira Neto AA, Bordalo-Rodrigues M, de Camargo OP. Clinical and Structural Evaluations of Rotator Cuff Repair With and Without Added Platelet-Rich Plasma at 5-Year Follow-up: A Prospective Randomized Study. Am J Sports Med. 2018 Nov;46(13):3134-3141. doi: 10.1177/0363546518795895. Epub 2018 Sep 20.
Results Reference
derived

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Platelet Rich Plasma on Rotator Cuff Repair

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