None listed
Conditions
Brief summary
The clinical outcome of arthroscopic rotator cuff repair including pain and ROM is generally favourable Despite advances in surgical techniques for rotator cuff repair, postoperative non-healing of rotator cuff tendons (tendon re-tear) is a serious issue, with an incidence ranging between 20% and 95%. Given that re-tear rate after cuff repair is a serious issue, a number of approaches have been investigated to improve rotator cuff repair healing including advancements in the fields of repair materials, repair techniques, biological augmentation and rehabilitation protocols. In this study we examine the healing effect of HA after cuff repair taking in consideration that some in-vitro and animal studies have demonstrated a significant positive effect of HA on tendon healing. Moreover, the efficacy and safety of HA in some abdominal surgeries and as a non-surgical therapy in shoulder disorders has been widely reported.
Interventions
Hyaluronic Acid or sterile saline placebo, given as a single dose (4ml) subacromially 30 minutes after arthroscopic rotator cuff repair. The Coordinating Investigator (Orthopedic Fellow) will administer the fluid at the recovery room.
Sponsors
St Vincent's SportsMed
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adult patients with confirmed rotator cuff tear who will undergo arthroscopic shoulder rotator cuff repair surgery at St. Vincent’s Private Hospital and Nepean Private Hospital.
Exclusion criteria
• Advanced shoulder Arthritis • Patients below 18 years or above 75 years of age • Revision of previous cuff repair • Smokers • Irreparable cuff tear • Primary Shoulder instability (Bankart labral tear) • Rheumatoid arthritis / Inflammatory arthritis • Chronic pain syndrome
Outcome results
None listed