NCT01612845

Brief Summary

The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

June 4, 2012

Last Update Submit

June 5, 2012

Conditions

Rotator Cuff Tears of the Shoulder

Keywords

rotator cuffshoulderplatelet rich plasmafibrin

Outcome Measures

Primary Outcomes (1)

  • rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI

    one year

Secondary Outcomes (2)

  • functional outcome evaluated with constant score

    two years

  • disability outcome evaluated with dash score

    two years

Study Arms (2)

PRF

EXPERIMENTAL

the group in which the PRF was administered

Biological: PRF (vivostat ®) administration after rotator cuff repair

Control

ACTIVE COMPARATOR

repair without PRF

Procedure: Arthroscopic repair without platelet rich fibrin

Interventions

Arthroscopic repair without platelet rich fibrinPROCEDURE

after the tendon is repaired, no additional procedures are performed and no PRF is administered

Control
PRF (vivostat ®) administration after rotator cuff repairBIOLOGICAL

7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff

PRF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Massive rotator cuff tears affecting supraspinatus and infraspinatus
  • Failed conservative treatment for at least 6 months
  • No hematologic disorder

You may not qualify if:

  • Rotator cuff affecting subscapularis
  • chronic infectious disease
  • anemia
  • clot disorders
  • low platelet count
  • history of difficulty in venous puncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (4)

  • Jo CH, Kim JE, Yoon KS, Lee JH, Kang SB, Lee JH, Han HS, Rhee SH, Shin S. Does platelet-rich plasma accelerate recovery after rotator cuff repair? A prospective cohort study. Am J Sports Med. 2011 Oct;39(10):2082-90. doi: 10.1177/0363546511413454. Epub 2011 Jul 7.

    PMID: 21737832BACKGROUND

  • Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.

    PMID: 21570659BACKGROUND

  • Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.

    PMID: 21160018BACKGROUND

  • Barber FA, Hrnack SA, Snyder SJ, Hapa O. Rotator cuff repair healing influenced by platelet-rich plasma construct augmentation. Arthroscopy. 2011 Aug;27(8):1029-35. doi: 10.1016/j.arthro.2011.06.010.

    PMID: 21802625RESULT

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Samuel A Antuña, MD PhD

    H. La PAz

    STUDY DIRECTOR

  • Raul Barco, MD PhD

    HU La PAz

    PRINCIPAL INVESTIGATOR

  • Jose M Martinez, MD

    HU La Paz

    PRINCIPAL INVESTIGATOR

  • Jose M sanchez, MD

    HU La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Shoulder and Elbow Surgery

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

May 1, 2007

Primary Completion

May 1, 2009

Study Completion

June 1, 2011

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

ES(1)