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The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair

12. februar 2014 opdateret af: Robert Burks, University of Utah

Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears

The purpose of this study was to determine the effect of platelet-rich fibrin matrix (PRFM) augmentation to at-risk arthroscopic rotator cuff repairs on healing rates and functional outcome scores. The investigators performed an observational cohort study in which a consecutive series of patients with rotator cuff tears at risk for retear was prospectively evaluated after arthroscopic repair augmented with PRFM. Clinical and magnetic resonance imaging (MRI) outcomes of the PRFM-augmented repairs were compared with historical controls with similar at-risk tears without PRFM augmentation.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Increased age, larger tear size, and more advanced fatty degeneration of the rotator cuff musculature have been correlated with poorer healing rates after rotator cuff repair. Platelets are an endogenous source of growth factors present during rotator cuff healing.

The investigators hypothesis is that augmentation of rotator cuff repairs with platelet-rich fibrin matrix (PRFM) may improve the biology of rotator cuff healing and thus improve functional outcome scores and retear rates after repair.

Rotator cuff tears at risk for retear were prospectively identified using an algorithm; points were assigned for age (50-59 years = 1; 60-69 years = 2; .70 years = 3), anterior-to-posterior tear size (2-2.9 cm = 0; 3-3.9 cm = 1; .4 cm = 2), and fatty atrophy (Goutallier score 0-2 = 0; Goutallier score 3-4 = 1). Three points were required for enrollment. Arthroscopic rotator cuff repair was performed with the addition of PRFM. Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores were obtained. Imaging and functional outcomes were compared with historical controls meeting the same enrollment criteria.

Enrollment for the study began in September 2008 and continued until March 2010.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

37

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Utah
      • Salt Lake city, Utah, Forenede Stater, 84108
        • University Of Utah Orthopedics Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage that meet the inclusion/exclusion criteria were asked to participate.

Beskrivelse

Inclusion Criteria:

  • Algorithm score greater and equal to 3
  • Both men and women over the age of 50
  • Full-thickness rotator cuff tear at least 2 cm in size
  • Tear repairable by arthoscopic-only techniques

Exclusion Criteria:

  • Inflamation joint disease
  • Active use of oral steroids
  • Irreparable rotator cuff tear
  • Subscapularis tear requiring open repair
  • Claustrophobia
  • Prior rotator cuff sugery on the affected shoulder
  • Failure to return for follow-up magnetic resonance imaging scan

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
PRFM Group
Patients were selected prospectively for the study based on a 3-part algorithm used to identify rotator cuff tears at risk for retear. A total algorithm score of 3 or greater was required for enrollment in the study.
Control Group
The control group were recruited retrospectively. Patients who have undergone arthroscopic repair of rotator cuff tears with similar size characteristics without PRFM augmentation will be encouraged to participate by letter initially, and then by telephone invitation. The same inclusion and exclusion criteria applied. MRI, pain, and functional scores will be collected in the same manner as the PRFM group at one time point at least one year post operatively.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
Tidsramme: 1 year
Patients with symptomatic rotator cuff tears identified by clinical exam and MRI that measure greater than two centimeters or are retracted medially to the level of the humeral head cartilage. Shoulder pain scores, functional scores, and MRI data will be obtained pre-operatively and compared to the same data collected 1 year post-operatively.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

Efterforskere

  • Ledende efterforsker: Robert Burks, MD, University Of Utah Orthopedics Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

22. august 2011

Først indsendt, der opfyldte QC-kriterier

25. august 2011

Først opslået (Skøn)

29. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 29598

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rotator Cuff Tear Arthropathy

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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