Measuring the effect of Hyaluronic acid (HA) on tendon healing after arthroscopic rotator cuff repair

Phase 3

Recruiting

• Conditions: Rotator Cuff Tear; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12618001648213
• Lead Sponsor: St Vincent's SportsMed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-05
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retear rate of rotator cuff repair. 12 month MRI report will be checked by the consulting investigator and the Cuff tendon integrity will be documented according to the 5-stage Sugaya assessment system[12 months post rotator cuff repair]

Secondary Outcome Measures

Name	Time	Method
Change of range of motion from pre-operative using a goniometer, with the glenohumeral joint as reference.. Motion includes forward flexion, abduction/adduction, external/internal rotation. Range of motion will be recorded at the pre-operative visit by the orthopedic surgeons, and again at 6, 12, 24, and 48 weeks post-operatively[6, 12, 24, and 48 weeks post-rotator cuff repair];Shoulder function as assessed using the Constant Shoulder Score and ASES scoring systems[6, 12, 24, and 48 weeks post rotator cuff repair]