Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation

NCT ID: NCT01170312

Last Updated: 2012-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-08-31

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(ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets.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

Conditions

Rotator Cuff Tear

Keywords

Arthroscopic repair; Rotator cuff; Platelet rich plasma; Randomized; Pilot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Autologous conditioned plasma

Group Type: ACTIVE_COMPARATOR

Autologous conditioned plasma (ACP)

Intervention Type: BIOLOGICAL

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

Normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

Normal saline injection

Interventions

Autologous conditioned plasma (ACP)

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

Intervention Type: BIOLOGICAL

Normal saline

Normal saline injection

Intervention Type: OTHER

Other Intervention Names

Platelet rich plasma

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohit Bhandari, MD, MSc, PhD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

McMaster Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 20141991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18608363 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20068208 (View on PubMed)

Other Identifiers

PRP-123

Identifier Type: -

Identifier Source: org_study_id