Clinical trial NCT01170312: Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Arthroscopic repair
Rotator cuff
Platelet rich plasma
Randomized
Pilot
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2010-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. This study is interested in a technique that has the potential to improve patient outcomes in terms of less pain and better function after their surgery. Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets. Platelets release growth factors important for healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected into the shoulder at the time of surgery and again at 4 weeks. It has been shown to accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff tears. It is on this basis that the study is being performed. Participating patients will receive either a PRP injection or a placebo (normal saline) and the effects will be compared at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires. The primary hypothesis for this study is that ACP compared with placebo is effective in reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week pain scores compared to the placebo group.


Eligibility criteria: 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).

Primary outcomes:
measure: Pain score
timeFrame: 6 weeks
Secondary outcomes:
measure: Physical function
timeFrame: Up to and including 6 weeks
measure: Revision surgery
timeFrame: Up to and including 6 weeks
measure: Health utility
timeFrame: Up to and including 6 weeks
measure: Adverse events
timeFrame: Up to and including 6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Mohit Bhandari, MD, MSc, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.