- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170312
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (ASPIRE)
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (A.S.P.I.R.E.): The Use of Platelet Rich Plasma Following Arthroscopic Repair of Rotator Cuff Tears, A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada
- Hamilton General Hospital
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Hamilton, Ontario, Canada
- McMaster Hospital
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Hamilton, Ontario, Canada, L8L8E7
- McMaster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men or women who are between 18 and 70 years of age.
- Primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less.
- Rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis.
- Provision of informed consent.
Exclusion Criteria:
- Rotator cuff tears secondary to a fracture.
- Patients with an associated dislocation at the time of randomization.
- Rotator cuff tears that underwent prior surgical repair or revision arthroscopy.
- Non-surgical rotator cuff associated treatment in the 1 month prior to randomization including corticosteroid injection and anti-inflammatory treatment.
- Prior platelet rich plasma injection.
- Pre-existing conditions associated with upper extremity pain, including arthritis, ongoing infection, carpal tunnel syndrome, cervical neuropathy or other nerve pathology, local malignancy, and systemic disorders (e.g., uncontrolled diabetes, hypothyroidism).
- Patients with gross shoulder instability.
- Patients with an active infection.
- Patients who are pregnant or plan to become pregnant in the next 12 months.
- Patients with a pre-operative platelet count less than 125,000 and a pre-operative hemoglobin of 7.5g/dl or less.
- Likely problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support).
- Patients who do not read and speak English.
- Patients participating in another ongoing trial that would interfere with the assessment of the primary or secondary outcomes.
- Any other reason (in the judgment of the surgeon).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Normal saline
|
Normal saline injection
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Active Comparator: Autologous conditioned plasma
|
ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: 6 weeks
|
To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks. Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate their worst pain in their shoulder for the previous 24 hours on a 100 mm vertical scale with "0" indicating no pain at all and "100" indicating the worst pain the subject can imagine. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function
Time Frame: Up to and including 6 weeks
|
As measured by the Western Ontario Rotator Cuff Index (WORC), the Disabilities of the Arm, Shoulder and Hand Score (DASH), and the Constant Score, administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
|
Up to and including 6 weeks
|
Revision surgery
Time Frame: Up to and including 6 weeks
|
Up to and including 6 weeks
|
|
Health utility
Time Frame: Up to and including 6 weeks
|
As measured by the EuroQol-5 Dimensions (EQ-5D) administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery.
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Up to and including 6 weeks
|
Adverse events
Time Frame: Up to and including 6 weeks
|
Up to and including 6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohit Bhandari, MD, MSc, PhD, FRCSC, McMaster University
Publications and helpful links
General Publications
- de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.
- Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081.
- Lopez-Vidriero E, Goulding KA, Simon DA, Sanchez M, Johnson DH. The use of platelet-rich plasma in arthroscopy and sports medicine: optimizing the healing environment. Arthroscopy. 2010 Feb;26(2):269-78. doi: 10.1016/j.arthro.2009.11.015.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP-123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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