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ISRCTN
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ISRCTN49643328
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ClinicalTrials.gov identifier
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Public title
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Growth factors augmentation for arthroscopic rotator cuff repair
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Scientific title
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Efficacy and safety of growth factors augmentation for arthroscopic rotator cuff repair compared with non-augmented repair: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To test the hypothesis that growth factors augmentation results in increased improvement in shoulder function and better magnetic resonance imaging (MRI) appearance in patients undergoing arthroscopic repair of small or moderate rotator cuff tears.
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Lay summary
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Ethics approval
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Local ethics committee (Comitato etico dell’Ospedale di Iesi, ASUR MARCHE) approved on the 2nd January 2007
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Study design
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Interventional randomised single centre single-blind placebo-controlled cross-over study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Rotator-cuff tendon tear
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Participants - inclusion criteria
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1. Aged over 30 years, either sex
2. Rotator cuff tear diagnosed on clinical grounds
3. No episodes of shoulder instability
4. No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity
5. Magnetic resonance imaging evidence of cuff tear
6. A repairable full-thickness tear of the rotator cuff found at the time of surgery
7. Patients with associated biceps pathology are also included
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Participants - exclusion criteria
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1. Inflammatory joint disease
2. Irreparable full-thickness tear or partial thickness tear of the rotator cuff found at the time of surgery
3. Symptomatic arthritis of the acromioclavicular joint
4. Rotator cuff arthropathy
5. Pathologies of the subscapularis tendon
6. Workers' Compensation claims
7. Prior surgery on the affected shoulder
8. Inability to complete questionnaires because of language problem
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Anticipated start date
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03/01/2007
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Anticipated end date
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28/04/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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82 participants (41 participants per group)
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Interventions
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Study group:
Arthroscopic rotator cuff repair and augmentation with platelet-rich fibrin matrix (Cascade® Autologous Platelet System, Musculoskeletal Transplant Foundation [MTF]).
Control group:
Arthroscopic rotator cuff repair without augmentation with platelet-rich fibrin matrix (Cascade® Autologous Platelet System, MTF).
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Primary outcome measure(s)
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Difference in change from baseline to 16 months in the Constant Score between the two groups. The Constant Score is a scoring system shoulder rating scale evaluating shoulder pain (15 points), activities of daily living (20 points), range of movement (40 points), and power (25 points). Total possible score is 100 points, indicating an asymptomatic and healthy person, while the worst score is 0 points.
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Secondary outcome measure(s)
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Integrity of the repaired rotator cuff, as evaluated by MRI.
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Sources of funding
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Ospedale di Jesi (Italy)
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Trial website
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Publications
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Contact name
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Dr
Roberto
Castricini
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Address
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Asur marche
Ospedale di Jesi
U. O. Di ortopedia e traumatologia
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City/town
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Jesi
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Zip/Postcode
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60010
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Country
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Italy
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Sponsor
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Ospedale Civile (Italy)
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Address
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Viale della Vittoria n.76
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City/town
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Jesi
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Zip/Postcode
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60035
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Country
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Italy
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Sponsor website:
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http://www.asurzona5.marche.it
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Date applied
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06/01/2010
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Last edited
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02/02/2010
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Date ISRCTN assigned
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02/02/2010
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