NCT01170312

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(ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1.9 years

First QC Date

July 22, 2010

Last Update Submit

October 31, 2012

Conditions

Rotator Cuff Tear

Keywords

Arthroscopic repairRotator cuffPlatelet rich plasmaRandomizedPilot

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (4)

  • Physical function

    Up to and including 6 weeks

  • Revision surgery

    Up to and including 6 weeks

  • Health utility

    Up to and including 6 weeks

  • Adverse events

    Up to and including 6 weeks

Study Arms (2)

Autologous conditioned plasma

ACTIVE COMPARATOR
Biological: Autologous conditioned plasma (ACP)

Normal saline

PLACEBO COMPARATOR
Other: Normal saline

Interventions

Autologous conditioned plasma (ACP)BIOLOGICAL

ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.

Also known as: Platelet rich plasma
Autologous conditioned plasma
Normal salineOTHER

Normal saline injection

Normal saline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McMaster University

Hamilton, Ontario, L8L8E7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

McMaster Hospital

Hamilton, Ontario, Canada

Location

Related Publications (3)

  • 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.

    PMID: 20141991BACKGROUND

  • 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.

    PMID: 18608363BACKGROUND

  • 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.

    PMID: 20068208BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mohit Bhandari, MD, MSc, PhD, FRCSC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 27, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

CA(3)