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Trial registered on ANZCTR


Registration number
ACTRN12607000654459
Ethics application status
Approved
Date submitted
18/12/2007
Date registered
21/12/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of intra-articular hyaluronan (Synvisc®) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus)
Scientific title
In people with osteoarthritis of the first metatarsophalangeal joint of the foot (hallux limitus), is intra-articular hyaluronan (Synvisc) an effective intervention (compared to placebo) for reducing pain and improving function
Secondary ID [1] 252818 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the first metatatarsophalangeal joint (hallux limitus) 2647 0
Condition category
Condition code
Musculoskeletal 2761 2761 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hylan GF-20 (up to 1ml) will be given as a single intra-articular injection. Participants will have the option for a second and final intervention (up to 1ml) on day 30 or day 90 after the intervention
Intervention code [1] 2382 0
Treatment: Drugs
Comparator / control treatment
Saline (up to 1ml) will be given as a single intra-articular injection. Participants will have the option for a second and final intervention (up to 1ml) on day 30 or day 90 after the intervention
Control group
Placebo

Outcomes
Primary outcome [1] 3648 0
Pain sub-score of the Foot Health Status Questionnaire
Timepoint [1] 3648 0
Baseline, 1, 3 and 6 months after the intervention commencement
Primary outcome [2] 3649 0
Function sub-score of the Foot Health Status Questionnaire
Timepoint [2] 3649 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [1] 6123 0
Pain during motion (Visual Analogue Scale)
Timepoint [1] 6123 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [2] 6124 0
Pain during rest (Visual Analogue Scale)
Timepoint [2] 6124 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [3] 6125 0
Stiffness during motion at the first metatarsophalangeal joint (Visual Analogue Scale)
Timepoint [3] 6125 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [4] 6126 0
Non-weightbearing range of motion of the first metatarsophalangeal joint, measured using a goniometer
Timepoint [4] 6126 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [5] 6127 0
Plantar-flexion strength of the toe-flexor muscles of the hallux, measured using the Mat Scan plantar pressure measurement device
Timepoint [5] 6127 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [6] 6128 0
Global satisfaction with treatment intervention, using a 5-point Likert scale
Timepoint [6] 6128 0
1, 3 and 6 months after the intervention commencement
Secondary outcome [7] 6129 0
Global satisfaction with treatment intervention, using a dichotomous scale (Yes/No)
Timepoint [7] 6129 0
1, 3 and 6 months after the intervention commencement
Secondary outcome [8] 6130 0
Health related quality of life, measured using the SF-36 questionnaire
Timepoint [8] 6130 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [9] 6133 0
Inclusion: Changes in dynamic plantar pressure (maximum force and peak pressure), stiffness duration (4-point scale)and use of rescue medications to relieve pain at the first metatarsophalangeal joint
Timepoint [9] 6133 0
at 7 months or 9 months (in those participants that receive the option of a second and final intervention on day 30 or 90 after the intervention respectively)
Secondary outcome [10] 6134 0
Magnitude of symptom change (15-point Likert scale)
Timepoint [10] 6134 0
1, 3 and 6 months after the intervention commencement
Secondary outcome [11] 8902 0
Stiffness duration, using a four category scale
Timepoint [11] 8902 0
Baseline, 1, 3 and 6 months after the intervention commencement
Secondary outcome [12] 8903 0
Changes in dynamic plantar pressures (maximum force and peak pressure)(relative to baseline assessment)
Timepoint [12] 8903 0
1, 3 and 6 months after the intervention commencement
Secondary outcome [13] 8904 0
Use of rescue medications to relieve pain at the first metatarsophalangeal joint
Timepoint [13] 8904 0
1, 2, 3, 4, 5 and 6 months after the intervention commencement

Eligibility
Key inclusion criteria
i) be aged at least 18 years;
ii) report having symptoms of pain during motion or rest, and stiffness in the first metatarsophalangeal joint for at least 3 months;
iii) report having pain rated at least 20mm on a 100mm visual analogue pain scale (VAPS);
iv) have pain upon palpation of the dorsal aspect of the first metatarsophalangeal joint;
v) Radiographic evidence of osteoarthritis (score 1 or 2 for either osteophytes or joint space narrowing using radiographic classification described by Menz et al.[2007]) at the first metatarsophalangeal joint;
vi) be normally active and able to walk household distances (>50 meters) without the aid of a walker, crutches or cane;
vii) be willing to attend the La Trobe University Medical Centre for treatment with either Synvisc® or placebo (single intra-articular injection) and attend the Health Sciences Clinic of La Trobe University for the initial assessment and the outcome measurements (at baseline and 1, 3 and 6 months post-treatment);
viii) not receive other intra-articular injections into the first metatarsophalangeal joint, apart from the study intervention, during the course of the study;
(ix) be willing to discontinue taking all pain-relieving medications (analgesics and non-steroidal anti-inflammatory medications, except paracetamol up to 4g/day, taken by mouth or applied topically):
- for at least 14 days prior to the initial assessment;
- during the study period (6 months after the final treatment with Synvisc®).
Participants who do take paracetamol need to discontinue its use at least 24 hours prior to the:
- initial assessment;
- follow-up assessments at 1, 3 and 6 months after the treatment with Synvisc®;
(x) be willing to not receive any physical therapy on the involved first metatarsophalangeal joint or trial of shoe modifications or orthotics during the study period.
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) No radiographic evidence of osteoarthritis (score 0 for osteophytes and joint space narrowing using radiographic classification described by Menz et al.[2007]), or severe radiographic evidence of osteoarthritis (score 3 for either osteophytes or joint space narrowing using radiographic classification described by Menz et al.[2007]) at the first metatarsophalangeal joint;
ii) previous surgery on the first metatarsophalangeal joint;
iii) intra-articular steroid, or any other intra-articular injection at the first metatarsophalangeal joint, in the previous 6 months;
iv) treatment with systemic steroid (excluding inhalation or topical steroids), immunosuppressives or anticoagulants (except for acetylsalicylic acid at dosages of up to 325 mg/day);
v) presence of joint infections of the foot;
vi) significant deformity of the first metatarsophalangeal joint including hallux abducto valgus;
vii) presence of peripheral vascular disease;
viii) presence of one or more conditions that can confound pain and functional assessments of the first metatarsophalangeal joint, such as significant hallux abducto valgus, metatarsalgia, plantar fasciitis, pre-dislocation syndrome, sprains of the foot, Achilles tendinopathy, degenerative joint disease of the foot (other than the first metatarsophalangeal joint) or painful corns and callus;
ix) planning to undergo any surgical procedure or receive any injections at the involved first metatarsophalangeal joint during the study period;
x) presence of systemic inflammatory condition or infection, such as inflammatory arthritis, diagnosed with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, septic arthritis, gout/acute pseudogout, or any other connective tissue disease;
xi) Evidence of gout or other musculoskeletal disease other than osteoarthritis within the feet. Gout will be screened for using clinical history and physical assessment (painful joint, abrupt onset, swelling), radiographic assessment (asymmetrical joint swelling, subcortical cysts without erosion and tophi) as well as serum uric acid levels;
xii) active skin disease or infection in the area of the injection site;
xiii) any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, bleeding disorder, clinically important pain in a part of the musculoskeletal system other than the first metatarsophalangeal joint, or fibromyalgia);
xiv) pregnant or lactating women, or women who are of child bearing age or have not undergone menopause (Synvisc® has not been tested in pregnant women or women who are nursing);
xv) cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire);
xvi) known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations, or to avian proteins, feathers, and egg products;
xvii) Involvement in any clinical research study in the previous 3 months that could be considered to affect the results of this study.

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)
The allocation sequence will be generated and held by an external person not directly involved in the trial. Concealment of the allocation sequence will be ensured as each participant’s allocation will be contained in a sealed opaque envelope. Participants as well as the person performing the outcome measurements will be blinded as to which intervention the participants have received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to either the Synvisc® or placebo groups will be achieved using a computer generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be given the option of a second and final intra-articular injection (of Synvisc® or sterile saline according to the treatment group they are in) after 1 month or 3 months after treatment commences if there is no improvement in pain (assessed using the Visual Analogue Scale for pain during motion or at rest) and the participant has not experienced severe adverse effects after the first injection.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2900 0
University
Name [1] 2900 0
La Trobe University
Country [1] 2900 0
Australia
Funding source category [2] 2901 0
Charities/Societies/Foundations
Name [2] 2901 0
Australian Podiatry Education and Research Foundation
Country [2] 2901 0
Australia
Funding source category [3] 2902 0
Commercial sector/Industry
Name [3] 2902 0
Genzyme Australasia (partial grant)
Country [3] 2902 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 2620 0
None
Name [1] 2620 0
Address [1] 2620 0
Country [1] 2620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4843 0
University Human Ethics Committee - La Trobe University
Ethics committee address [1] 4843 0
Ethics committee country [1] 4843 0
Australia
Date submitted for ethics approval [1] 4843 0
Approval date [1] 4843 0
17/07/2007
Ethics approval number [1] 4843 0
07-45

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28253 0
Address 28253 0
Country 28253 0
Phone 28253 0
Fax 28253 0
Email 28253 0
Contact person for public queries
Name 11410 0
Shannon Munteanu
Address 11410 0
La Trobe University,
Department of Podiatry
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country 11410 0
Australia
Phone 11410 0
+61 3 94795866
Fax 11410 0
+61 3 94795768
Email 11410 0
s.munteanu@latrobe.edu.au
Contact person for scientific queries
Name 2338 0
Shannon Munteanu
Address 2338 0
La Trobe University,
Department of Podiatry
Faculty of Health Sciences
Corner Kingsbury Drive and Plenty Road
Bundoora VIC 3086
Country 2338 0
Australia
Phone 2338 0
+61 3 94795866
Fax 2338 0
+61 3 94795768
Email 2338 0
s.munteanu@latrobe.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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