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

NCT01000935 | Completed Phase 2 DMC

• 1 other identifier: 2009-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Rotator Cuff Pathology

Keywords

Rotator Cuff Decompression Repair

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Pain Scale

  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 Outcomes (3)

• Adverse Effect

  6 months

• Magnetic resonance Imaging (MRI)

  6 months after surgery

• Patient- focused outcomes

  Before surgery and 3 and 6 months following surgery

Study Arms (2)

Platelet Rich Plasma

ACTIVE COMPARATOR

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

Surgical repair (standard-of-care)

NO INTERVENTION

Patients will have a rotator cuff repair without the PRP application.

Interventions

Platelet Rich Plasma OTHER

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.

Platelet Rich Plasma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4Y1H1, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• Holtby R, Christakis M, Maman E, MacDermid JC, Dwyer T, Athwal GS, Faber K, Theodoropoulos J, Woodhouse LJ, Razmjou H. Impact of Platelet-Rich Plasma on Arthroscopic Repair of Small- to Medium-Sized Rotator Cuff Tears: A Randomized Controlled Trial. Orthop J Sports Med. 2016 Sep 13;4(9):2325967116665595. doi: 10.1177/2325967116665595. eCollection 2016 Sep.

  PMID: 27660800 BACKGROUND

Related Links

• Online access

Study Officials

• Richard Holtby, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Intevention involved PRP injection

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: October 23, 2009
• Study Start: March 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)