Rotator Cuff Pathology Clinical Trial
Official title:
Impact of Autologous Platelet Rich Plasma on Enhancing Repair of Rotator Cuff Tendons: A Multicentre Randomized Controlled Trial
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.
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