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Trial registered on ANZCTR


Registration number
ACTRN12618001648213
Ethics application status
Approved
Date submitted
1/10/2018
Date registered
5/10/2018
Date last updated
10/09/2019
Date data sharing statement initially provided
10/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the effect of Hyaluronic acid (HA) on tendon healing after arthroscopic rotator cuff repair
Scientific title
Measuring the effect of Hyaluronic acid (HA) on tendon healing after arthroscopic rotator cuff repair
Secondary ID [1] 296195 0
none
Universal Trial Number (UTN)
U1111-1221-3129
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Tear 309834 0
Condition category
Condition code
Musculoskeletal 308623 308623 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312523 0
Treatment: Drugs
Comparator / control treatment
Control group will receive sterile saline injection (4ml) as placebo
Control group
Placebo

Outcomes
Primary outcome [1] 307611 0
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
Timepoint [1] 307611 0
12 months post rotator cuff repair
Secondary outcome [1] 352419 0
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
Timepoint [1] 352419 0
6, 12, 24, and 48 weeks post-rotator cuff repair
Secondary outcome [2] 352420 0
Shoulder function as assessed using the Constant Shoulder Score and ASES scoring systems
Timepoint [2] 352420 0
6, 12, 24, and 48 weeks post rotator cuff repair

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Only the coordinating investigator will be aware of the patient's allocation, using a central computer. The principal investigators will be blinded of the patient's allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using a table generated from a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Nominal data will be expressed as means +/- SD, while categorical data will be expressed as mean, frequencies, +/- SD. The Mann-Whitney U-test will be utilized to determine significant difference in outcome measures between two groups. Friedman’s test will be used to determine significant difference in outcome measures over time.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/11/2018
Actual
28/03/2019
Date of last participant enrolment
Anticipated
28/03/2020
Actual
Date of last data collection
Anticipated
28/03/2021
Actual
Sample size
Target
90
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14754 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 14755 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 27986 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 27987 0
2474 - Kingswood

Funding & Sponsors
Funding source category [1] 300785 0
Commercial sector/Industry
Name [1] 300785 0
Surgical Specialties Pty Ltd
Country [1] 300785 0
Australia
Primary sponsor type
Individual
Name
St Vincent's SportsMed
Address
Level 5, St, Vincent's Clinic
438 Victoria St
Darlinghurst, NSW
2010
Country
Australia
Secondary sponsor category [1] 300333 0
None
Name [1] 300333 0
Address [1] 300333 0
Country [1] 300333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301569 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 301569 0
Nepean Hospital
Derby Street
Penrith, NSW 2750
Ethics committee country [1] 301569 0
Australia
Date submitted for ethics approval [1] 301569 0
05/10/2018
Approval date [1] 301569 0
Ethics approval number [1] 301569 0
Ethics committee name [2] 301589 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [2] 301589 0
St. Vincent's Hospital
438 Victoria Street
Darlinghurst, NSW 2010
Ethics committee country [2] 301589 0
Australia
Date submitted for ethics approval [2] 301589 0
05/10/2018
Approval date [2] 301589 0
19/02/2019
Ethics approval number [2] 301589 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3130 3130 0 0
/AnzctrAttachments/376090-HA study protocol 25Sep .docx (Protocol)
Attachments [2] 3131 3131 0 0
/AnzctrAttachments/376090-1st check point (1).docx (Other)
Attachments [3] 3132 3132 0 0
/AnzctrAttachments/376090-HA and cuff repair study- Patient information and consent form (2).docx (Participant information/consent)
Attachments [4] 3135 3135 0 0
/AnzctrAttachments/376090-HREC Cover Letter.pdf (Other)
Attachments [5] 3136 3136 0 0
/AnzctrAttachments/376090-2nd check point.docx (Other)
Attachments [6] 3137 3137 0 0
/AnzctrAttachments/376090-3rd check point (1).docx (Other)
Attachments [7] 3138 3138 0 0
/AnzctrAttachments/376090-4th check point (1).docx (Other)
Attachments [8] 3139 3139 0 0
/AnzctrAttachments/376090-5th check point (1).docx (Other)

Contacts
Principal investigator
Name 87418 0
A/Prof Simon Tan
Address 87418 0
St. Vincent's SportsMed
Level 5 St. Vincent's Clinic
438 Victoria St
Darlinghurst, NSW
2010
Country 87418 0
Australia
Phone 87418 0
+61 283826969
Fax 87418 0
Email 87418 0
[email protected]
Contact person for public queries
Name 87419 0
Simon Tan
Address 87419 0
St. Vincent's SportsMed
Level 5 St. Vincent's Clinic
438 Victoria St
Darlinghurst, NSW
2010
Country 87419 0
Australia
Phone 87419 0
+61 283826969
Fax 87419 0
Email 87419 0
[email protected]
Contact person for scientific queries
Name 87420 0
Simon Tan
Address 87420 0
St. Vincent's SportsMed
Level 5 St. Vincent's Clinic
438 Victoria St
Darlinghurst, NSW
2010
Country 87420 0
Australia
Phone 87420 0
+61 283826969
Fax 87420 0
Email 87420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect patient privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4589Informed consent form    Contact the office of St Vincent's SportsMed (02 8... [More Details] 376090-(Uploaded-06-09-2019-10-07-34)-Study-related document.pdf



Results publications and other study-related documents

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