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

Phase 2

Completed

• Conditions: Rotator Cuff Pathology
• Interventions: Other: Platelet Rich Plasma

• Registration Number: NCT01000935
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2011-03
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse Effect	6 months
Patient- focused outcomes	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
Magnetic resonance Imaging (MRI)	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.

Trial Locations

Locations (2)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada