The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
Effects of Platelet-Rich Fibrin Matrix on Repair Integrity of At-Risk Rotator Cuff Tears
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Utah
-
Salt Lake city, Utah, Stati Uniti, 84108
- University Of Utah Orthopedics Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Robert Burks, MD, University Of Utah Orthopedics Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 29598
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .