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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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Rotator Cuff Pathology
Platelet Rich Plasma, Platelet Rich plasma
St. Joseph's Health Centre,
Not yet recruiting
Sunnybrook Health Sciences Centre
Published on BioPortfolio: 2014-08-27T03:18:27-0400
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Compression of the rotator cuff tendons and subacromial bursa between the humeral head and structures that make up the coracoacromial arch and the humeral tuberosities. This condition is associated with subacromial bursitis and rotator cuff (largely supraspinatus) and bicipital tendon inflammation, with or without degenerative changes in the tendon. Pain that is most severe when the arm is abducted in an arc between 40 and 120 degrees, sometimes associated with tears in the rotator cuff, is the chief symptom. (From Jablonski's Dictionary of Syndromes and Eponymic Diseases, 2d ed)
Injuries to the ROTATOR CUFF of the shoulder joint.
Rapidly destructive shoulder joint and bone disease found mainly in elderly, and predominantly in women. It is characterized by SHOULDER PAIN; JOINT INSTABILITY; and the presence of crystalline CALCIUM PHOSPHATES in the SYNOVIAL FLUID. It is associated with ROTATOR CUFF INJURIES.
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