Clinical trial NCT01000935: Impact of Autologous Platelet Rich Plasma on Healing of Rotator Cuff Repairs
Official title: Impact of Autologous Platelet Rich Plasma on Enhancing Repair of Rotator Cuff Tendons: A Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rotator Cuff Pathology
Keywords: Rotator Cuff Decompression Repair
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
First posted: 2009-10-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intevention involved PRP injection
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Visual Analogue Pain Scale
timeFrame: 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:
measure: Adverse Effect
timeFrame: 6 months
measure: Magnetic resonance Imaging (MRI)
timeFrame: 6 months after surgery
measure: Patient- focused outcomes
timeFrame: Before surgery and 3 and 6 months following surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Richard Holtby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.