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Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000935
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : March 19, 2020
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Dr. Helen Razmjou, Sunnybrook Health Sciences Centre

Brief Summary:

Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions that often require surgical treatment. Initial efforts to improve tendon healing centered on improving the strength of the repair construct. More recent studies have focused on biologic enhancement of the healing process. The use of platelet concentrates to improve healing, has been explored considerably during the last decade. Platelet Rich Plasma (PRP) is a fraction of plasma that has been isolated and used to enhance regeneration in bone and soft tissues.

There is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon, and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that have examined the impact of PRP in patients with rotator cuff tear.

The objective of the proposed pilot study is to examine the effectiveness of autologous Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons following arthroscopic rotator cuff repair through a randomized controlled study.

Condition or disease Intervention/treatment Phase
Rotator Cuff Pathology Other: Platelet Rich Plasma Phase 2

Detailed Description:

Surgical procedures: Arthroscopic inspection of the shoulder will be performed to assess intra-articular structures and to evaluate the rotator cuff and other sub-acromial structures.

Arthroscopic Rotator Cuff Repair: Rotator cuff tears will be categorized as partial-thickness and full-thickness tears. The full-thickness tears will be classified as small (<1 cm), moderate (1-3 cm), and large (>3-5 cm) based on the largest dimension and will be treated with a repair using sutures and suture anchors as indicated.

Rehabilitation: A comprehensive protocol with instructions on different types of exercises will be provided pre-operatively. Rehabilitation will be based on the standard protocols for these procedures used at the Holland Centre.

Follow-ups: Patients will be monitored for 6 months, or when participation is terminated by the investigators, or because the patient withdrew consent or fails to return for visits. To evaluate safety, clinical laboratory (WBC, Hb, platelet count, serum chemistry and IL-6, CRP, PT, PTT and INR tests will be conducted at 6 weeks, and 3 months to determine the impact of treatment interventions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intevention involved PRP injection
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Autologous Platelet Rich Plasma on Enhancing Repair of Rotator Cuff Tendons: A Multicentre Randomized Controlled Trial
Study Start Date : March 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: Platelet Rich Plasma
The platelet concentrate extracted from patient's own blood (PRP) will be applied to the surgical site after completion of the repair.
Other: Platelet Rich Plasma
Patient's blood will be drawn prior to the start of the procedure. The processing disposable (PD) size of 60ml will be used to yield 7 ml of Platelet concentrate volume. Using the lateral portal, the applicator for the PRP will be positioned in between the bone and the repaired rotator cuff without a cannula. The inflow will then be closed and the arthroscopic fluid will be aspirated via the outflow cannula. All other cannulae will be removed, producing a dry subacromial space. The PRP and autologous thrombin will then be transferred to the sterile field and drawn up into a dedicated spray applicator kit (Smartjet) and applied to the site of repair. A dry arthroscopic check will be performed to evaluate the clot formation of the applied solution.

No Intervention: Surgical repair (standard-of-care)
Patients will have a rotator cuff repair without the PRP application.

Primary Outcome Measures :
  1. Visual Analogue Pain Scale [ Time Frame: The primary outcome will be collected pre and post-operatively. The level of pain and medication utilization will be monitored throughout the study by completing a pain diary (day 1-30) and at 6 weeks, 3 months and 6 months following surgery. ]

Secondary Outcome Measures :
  1. Adverse Effect [ Time Frame: 6 months ]
  2. Magnetic resonance Imaging (MRI) [ Time Frame: 6 months after surgery ]
    The main secondary evaluation tool is the healing index examined by the post-operative MRI. In order to assess tendon healing, anatomic evaluation of the cuff repair will be done with use of a MRI as the investigation of choice. A postoperative MRI will be performed at a minimum of six months following surgery. The images will be reviewed by a senior radiologist who is blinded to patient group allocation.

  3. Patient- focused outcomes [ Time Frame: Before surgery and 3 and 6 months following surgery ]
    1. The SHORT Western Ontario Rotator Cuff Index
    2. The American Shoulder and Elbow Surgeons (ASES) form
    3. The Constant- Murley Score (CM) outcome measure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Age >18 years
  2. Diagnosis of partial or full-thickness rotator cuff tear of less or equal to 3 cm. confirmed by MRI or US within a period of 6 months prior to booking surgery.
  3. The final inclusion will be based on arthroscopic assessment of the tear size and lack of significant concurrent pathology.

Exclusion Criteria

  1. Unable to speak or read English
  2. Non-repairable tear
  3. Acute tears (<6 month)
  4. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory arthropathy, frozen shoulder
  5. Concurrent pathology of Superior Labral Anterior and Posterior (SLAP) lesions, Bankart lesions, or advanced osteoarthritis of the glenohumeral joint
  6. Previous surgery of the affected shoulder
  7. Bone marrow pathology
  8. Abnormal platelet count
  9. Serum hemoglobin concentration <11 g/dL or hematocrit <34%
  10. Use of systemic cortisone
  11. Current use of anticoagulants (i.e. Aspirin)
  12. Use of an investigational drug and/or blood donation within the previous 3 months prior to surgery
  13. Substance or alcohol abuse
  14. Heavy smoking [a daily cigarettes consumption of more than 20 pieces, based on definition of the World Health Organization (WHO)]
  15. Psychiatric illness that precludes informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01000935

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4Y1H1
Mount Sinai Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada
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Principal Investigator: Richard Holtby, MD Sunnybrook Health Sciences Centre
Additional Information:
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Responsible Party: Dr. Helen Razmjou, Research Associate, Sunnybrook Health Sciences Centre Identifier: NCT01000935    
Other Study ID Numbers: 2009-01
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Helen Razmjou, Sunnybrook Health Sciences Centre:
Rotator Cuff Decompression Repair