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Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (ASPIRE)

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Autologous conditioned plasma (ACP)
Normal saline
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Arthroscopic repair, Rotator cuff, Platelet rich plasma, Randomized, Pilot

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • McMaster University
  • Hamilton General Hospital
  • McMaster Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Autologous conditioned plasma

Normal saline

Arm Description

Outcomes

Primary Outcome Measures

Pain score
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.

Secondary Outcome Measures

Physical function
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.
Revision surgery
Health utility
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.
Adverse events

Full Information

First Posted
July 22, 2010
Last Updated
October 31, 2012
Sponsor
McMaster University
Collaborators
Arthrex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01170312
Brief Title
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
Acronym
ASPIRE
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Arthrex, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Arthroscopic repair, Rotator cuff, Platelet rich plasma, Randomized, Pilot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous conditioned plasma
Arm Type
Active Comparator
Arm Title
Normal saline
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Autologous conditioned plasma (ACP)
Other Intervention Name(s)
Platelet rich plasma
Intervention Description
ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Normal saline injection
Primary Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Physical function
Description
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.
Time Frame
Up to and including 6 weeks
Title
Revision surgery
Time Frame
Up to and including 6 weeks
Title
Health utility
Description
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.
Time Frame
Up to and including 6 weeks
Title
Adverse events
Time Frame
Up to and including 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Bhandari, MD, MSc, PhD, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L8E7
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
McMaster Hospital
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20141991
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.
Results Reference
background
PubMed Identifier
18608363
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.
Results Reference
background
PubMed Identifier
20068208
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.
Results Reference
background

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Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation

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