- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01424969
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Utah
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Salt Lake city, Utah, Förenta staterna, 84108
- University Of Utah Orthopedics Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Preoperative and 1-year postoperative magnetic resonance imaging (MRI) and functional outcome scores
Tidsram: 1 year
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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.
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1 year
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Robert Burks, MD, University Of Utah Orthopedics Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 29598
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Kliniska prövningar på Rotator Cuff Tear Arthropathy
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Zimmer, GmbHAktiv, inte rekryterandeManschett-tear artropatiTyskland, Belgien, Schweiz, Storbritannien
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Istituto Ortopedico RizzoliRekrytering
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William Beaumont HospitalsAvslutadRotator Cuff Tear ArthropathyFörenta staterna
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Arthrex, Inc.RekryteringRotator Cuff Tear ArthropathyFörenta staterna
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Gülçe İrem YalçınkayaAktiv, inte rekryterande
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University of California, San FranciscoAktiv, inte rekryterandeRotator Cuff Tear ArthropathyFörenta staterna
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University of Missouri-ColumbiaAvslutadSkulderartros | Cuff Tear Artropati | Massiv rotator manschettavrivningFörenta staterna
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Nova Scotia Health AuthorityAktiv, inte rekryterande
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Schulthess KlinikIndragenRotator Cuff Tear Arthropathy