NCT01029574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

5.3 years

First QC Date

December 9, 2009

Last Update Submit

December 2, 2014

Conditions

Rotator Cuff Tears

Keywords

Rotator cuff lesionsPlatelet rich plasmaArthroscopic repair

Outcome Measures

Primary Outcomes (1)

  • UCLA Score

    12 months

Secondary Outcomes (1)

  • Constant Scores and Re-tear rate (MRI)

    12 months

Study Arms (2)

Rotator cuff repair plus PRP

EXPERIMENTAL

Conventional arthroscopic repair of rotator cuff with application of PRP.

Other: Platelet rich plasma

Rotator cuff repair alone

PLACEBO COMPARATOR

Conventional arthroscopic repair of rotator cuff without application of PRP

Other: Platelet rich plasma

Interventions

Platelet rich plasmaOTHER

Ultra-centrifuged PRP, 40ml, in the liquid way, after portal closure.

Rotator cuff repair aloneRotator cuff repair plus PRP

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of São Paulo - Orthopedics and traumatology department

São Paulo, São Paulo, 05403-010, Brazil

Location

University of São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 30234999DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Eduardo A Malavolta, MD

    University of Sao Paulo - Orthopedic and Traumatology Department

    PRINCIPAL INVESTIGATOR

  • Arnaldo A Ferreira Neto, PhD

    University of Sao Paulo - Orthopedic and Traumatology Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

BR(2)