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

This study is currently recruiting participants.
Verified August 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Dr. Helen Razmjou, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01000935
First received: September 23, 2009
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Rotator Cuff Pathology
Other: Platelet Rich Plasma
Other: Platelet Rich plasma
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Magnetic resonance Imaging (MRI) [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    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.

  • Patient- focused outcomes [ Time Frame: Before surgery and 3 and 6 months following surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Surgical repair (standard-of-care)
Patients will have a rotator cuff repair without the PRP application.
Other: Platelet Rich plasma
The study group will have a surgical repair and will receive PRP treatment where the control group will undergo surgery without the PRP application.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000935

Contacts
Contact: Helen Razmjou, PhD helen.razmjou@sunnybrook.ca
Contact: Gail Gunnis gail.gunnis@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4Y1H1
Contact: Helen Razmjou, PhD    416-967-8654    helen.razmjou@sunnybrook.ca   
Principal Investigator: Richard Holtby, FRCSC         
Sub-Investigator: Helen Razmjou, PhD         
Sub-Investigator: Monique Christakis, MD, FRCPC         
Sub-Investigator: Linda Woodhouse, PhD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: Courtney Sponagle    416.586.4800 ext 8699    CSponagle@mtsinai.on.ca   
Principal Investigator: John Theodoropoulos, FRCSC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Richard Holtby, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Helen Razmjou, Research Associate, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01000935     History of Changes
Other Study ID Numbers: 2009-01
Study First Received: September 23, 2009
Last Updated: August 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Rotator Cuff Decompression Repair

ClinicalTrials.gov processed this record on April 16, 2014