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Trial registered on ANZCTR


Registration number
ACTRN12611000977976
Ethics application status
Approved
Date submitted
12/09/2011
Date registered
13/09/2011
Date last updated
13/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra-articular injections of hyaluronic acid in
osteoarthritis of the sub-talar joint:
A prospective study
Scientific title
In patients with subtalar osteoarthritis, does hyaluronic acid improve pain and daily function?
Secondary ID [1] 263034 0
Nil
Universal Trial Number (UTN)
U1111-1124-5158
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arthritis of the subtalar joint 270760 0
Condition category
Condition code
Musculoskeletal 270941 270941 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intra-articular injections of 10 mg HA were administered weekly to the sub-talar joint for 3 weeks
Intervention code [1] 269375 0
Treatment: Drugs
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279609 0
ankle hind foot score
Timepoint [1] 279609 0
4,12,28 weeks post treatment
Secondary outcome [1] 294030 0
The VAS questionnaire consisted of a series of questions, each with a score that ranged from 1 to 10. The questionnaire evaluated the degree of pain, joint stiffness and functional disabilities.
Timepoint [1] 294030 0
4,12,28 weeks post treatment

Eligibility
Key inclusion criteria
We included patients suffering from OA of the sub-talar joint grades II-III according to Paley Hall sub-talar joint grading system and grades II-IV according to the Kellgren & Lawrence. All patients complained of pain on motion or rest for at least 6 months and had swelling and tenderness of the sub-talar joint.
Minimum age
20 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included non-walking patients, those with an ankylosed subtalar joint, suspected or proven previous sub-talar joint infection, and those with known hypersensitivity to hyaluronic acid, pregnant or lactating women, patients with concomitant disease that may affect joints, those with open wounds or skin ulcers, and those taking anticoagulants or having a prolonged bleeding time. Patients who had undergone lower limb intra-articular injection or surgery, including arthroscopy, within the previous 6 months were also excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were recruited at our Foot And Ankle Referral Center of our University Hospital in the period 2008 to 2009. Patients were given a thorough explanation regarding the treatment, and gave their informed consent for inclusion, data collection and follow up.

Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3839 0
Israel
State/province [1] 3839 0

Funding & Sponsors
Funding source category [1] 269834 0
Hospital
Name [1] 269834 0
Meir University hospital
Address [1] 269834 0
Meir University Hospital
59 Tchernichovsky Street
Kfar-Saba
44281
Country [1] 269834 0
Israel
Primary sponsor type
Hospital
Name
Meir University hospital
Address
Meir University Hospital
59 Tchernichovsky Street
Kfar-Saba
44281
Country
Israel
Secondary sponsor category [1] 268866 0
Individual
Name [1] 268866 0
Omer Mei-Dan
Address [1] 268866 0
Moshav Bazra,
7 yonek hadvash st.
ZC 60944
Country [1] 268866 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271802 0
Institutional Review Board - Meir university hospital
Ethics committee address [1] 271802 0
59 Tchernichovsky Street
Kfar-Saba,
44281
Ethics committee country [1] 271802 0
Israel
Date submitted for ethics approval [1] 271802 0
07/08/2008
Approval date [1] 271802 0
04/09/2008
Ethics approval number [1] 271802 0
0195-08-MMC

Summary
Brief summary
The management for osteoarthritis (OA) of the sub-talar joint is primarily conservative. We evaluated the efficacy of intra-articular viscosupplementation with sodium hyaluronate (HA) in the management of OA of the sub-talar joint.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33150 0
Address 33150 0
Country 33150 0
Phone 33150 0
Fax 33150 0
Email 33150 0
Contact person for public queries
Name 16397 0
Omer Mei-Dan
Address 16397 0
Moshav Bazra,
7 yonek hadvash st.
ZC 60944
Country 16397 0
Israel
Phone 16397 0
+972-9-747-2549
Fax 16397 0
+972-9-747-1293
Email 16397 0
omer@extremegate.com
Contact person for scientific queries
Name 7325 0
Omer Mei-Dan
Address 7325 0
Moshav Bazra,
7 yonek hadvash st.
ZC 60944
Country 7325 0
Israel
Phone 7325 0
+972-9-747-2549
Fax 7325 0
+972-9-747-1293
Email 7325 0
omer@extremegate.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary