Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000098831
Ethics application status
Approved
Date submitted
4/11/2020
Date registered
1/02/2021
Date last updated
11/01/2023
Date data sharing statement initially provided
1/02/2021
Date results information initially provided
1/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Efficacy of a single or multiple intra-articular injections of hyaluronic acid in osteoarthritis.
Scientific title
Safety and Efficacy of a single or multiple intra-articular injections of hyaluronic acid in osteoarthritis.
Secondary ID [1] 302698 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 319614 0
Condition category
Condition code
Musculoskeletal 317558 317558 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data was obtained from patients who had treatment between January 2016 and December 2017 from patients who had received a single injection of hyaluronic acid (HA) (Durolane; and from patients who had had two or more injections up to December 2019. 3ml preparation) in accordance with the manufacturer’s guidelines as a part of their treatment with their surgeon or sports physician. This was performed according to standard hip injection technique with the patient supine using aseptic technique under ultrasound guidance. A sterile 21 g spinal needle was used with infiltration of 2-3 mls of lignocaine 2% (Xylocaine, Astra Zeneca, UK) sub-cuticularly and on the hip capsule. Durolane 3mls was then injected intra-articularly.
Intervention code [1] 318982 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325602 0
Change in modified Harris Hip Score
Timepoint [1] 325602 0
Change from baseline to 6 weeks
Secondary outcome [1] 388503 0
safety: reporting of any adverse events for example swelling or pain. This is clinician notes based on patient self reported symptoms
Timepoint [1] 388503 0
Data collected at baseline and 6 weeks
Secondary outcome [2] 404490 0
Time between injections of hyaluronic acid in days. This data was obtained from a review of the medical records
Timepoint [2] 404490 0
Timepoint 2 = date of second injection, Timepoint 3 = date of third injection, Timepoint 4-6 = date of 4th, 5th or 6th injection

Eligibility
Key inclusion criteria
Patients who have had one or more Durolane injections for osteoarthritis between January 2016 and December 2019
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients presenting with severe (Kellgren-Lawrence grade 4) OA,
2. inflammatory arthropathy
3. avascular necrosis.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Data collected in the medical record and transferred to a Microsoft Excel® spreadsheet. Each patient record assigned a unique study identification number. The results entered on a locked Excel spreadsheet (Microsoft), coded, and analysed. Statistical analysis conducted using STATA version 15 (StataCorp). Treatment comparisons based on the change in mHHS from baseline to 6 weeks, using the mean change with p-values < 0.05 required for statistical significance and 95% confidence intervals and a MCID of 10 points. The number of days between injections 2,3,4,5 and 6 will be analysed. Mean days and range will be recorded with between group difference at timepoints assessed by t-tests with p-values < 0.05 required for statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/01/2019
Date of last participant enrolment
Anticipated
Actual
23/12/2019
Date of last data collection
Anticipated
Actual
31/05/2021
Sample size
Target
653
Accrual to date
Final
653
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 31821 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 307133 0
Self funded/Unfunded
Name [1] 307133 0
Country [1] 307133 0
Primary sponsor type
Charities/Societies/Foundations
Name
Joint Health Institute
Address
10 Norford Grove Kooyong, VIC Australia 3144
Country
Australia
Secondary sponsor category [1] 307712 0
None
Name [1] 307712 0
Address [1] 307712 0
Country [1] 307712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307245 0
University of Melbourne, Faculty of Medicine, dentistry and Health Sciences HREC, Low risk
Ethics committee address [1] 307245 0
University of Melbourne, Parkville, Vic Australia. 3010
Ethics committee country [1] 307245 0
Australia
Date submitted for ethics approval [1] 307245 0
23/11/2018
Approval date [1] 307245 0
11/12/2018
Ethics approval number [1] 307245 0
1853383.1

Summary
Brief summary
The patients from which this data will be drawn were referred to the clinic by their general practitioner with symptomatic joint osteoarthritis for whom injection of hyaluronic acid (Durolane) was found to be the most appropriate treatment.
This data is collected on all patients undergoing such injections as a routine pre and post injection measures of their pain and function. For those who had more than one injection, the time in days between injections will be analysed.
Patient data will be included in the analyses if they were >18 years old with painful hip osteoarthritis and mild to moderate radiological changes on their imaging. There was no maximum age limit applied to the inclusion criteria. There were no specific inclusion or exclusion criteria in regards to race and gender.
The current data set of the patient cohort intended for analysis was collected over 4 years.The data from these patients who have recieved Durolane injections in normal clinical practice will be analysed retrospectively.
Trial website
Trial related presentations / publications
Public notes
Human Research Ethics approval was sought for this project in 2018 to examine data previously collected in the course of clinical practice from 1/1/2016 to 29/03/2018. Following ethics committee approval, the data was collected from January 2019 to March 2019. An amended approval in 2021 resulted in subsequent data collection from March 2021 to June 2021

Contacts
Principal investigator
Name 106546 0
A/Prof Jane Fitzpatrick
Address 106546 0
Sports Medicine Professionals, 21 Erin Street, Richmond VIC 3121
Country 106546 0
Australia
Phone 106546 0
+61 3 94296444
Fax 106546 0
Email 106546 0
[email protected]
Contact person for public queries
Name 106547 0
Mrs Sally Boyd
Address 106547 0
Sports Medicine Professionals, 21 Erin Street, Richmond VIC 3121
Country 106547 0
Australia
Phone 106547 0
+61 3 94296444
Fax 106547 0
Email 106547 0
[email protected]
Contact person for scientific queries
Name 106548 0
Mrs Sally Boyd
Address 106548 0
Sports Medicine Professionals, 21 Erin Street, Richmond VIC 3121
Country 106548 0
Australia
Phone 106548 0
+61 3 94296444
Fax 106548 0
Email 106548 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
All collected pooled data will be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Publication date 18 September 2021 https://pubmed... [More Details] 380872-(Uploaded-09-12-2022-14-30-03)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSafety and efficacy of a single intra-articular injection of hyaluronic acid in osteoarthritis of the hip: a case series of 87 patients.2021https://dx.doi.org/10.1186/s12891-021-04672-0
N.B. These documents automatically identified may not have been verified by the study sponsor.