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Trial registered on ANZCTR


Registration number
ACTRN12616001504404
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
31/10/2016
Date last updated
31/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health outcomes following SYNVISC-ONE in Knee Osteoarthritis
Scientific title
Longitudinal Study in Knee Osteoarthritis (OA) of Benchmarking Clinical Response and State-attainment following Viscosupplementation with SYNVISC-ONE (LOBRAS Study)
Secondary ID [1] 290372 0
None
Universal Trial Number (UTN)
Trial acronym
LOBRAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis (Knee) 300676 0
Condition category
Condition code
Musculoskeletal 300526 300526 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants received a single 6ml intra-articular SYNVISC-ONE, and were followed for the next 52 weeks
Intervention code [1] 296197 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299947 0
OA symptom severity assessed using the WOMAC Index. The WOMAC Index questionnaire was patient self-administered at baseline, and at Weeks 24 and 28. The value for Week 26 was derived by averaging values from Weeks 24 and 28.
Timepoint [1] 299947 0
26 weeks post SYNVISC-ONE procedure
Secondary outcome [1] 328633 0
OA symptom severity assessed using the WOMAC Index. The WOMAC Index questionnaire was patient self-administered.
Timepoint [1] 328633 0
Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The value for Week 26 was derived by averaging values from Weeks 24 and 28.
Secondary outcome [2] 328683 0
Health related quality of life assessed by SF36. The SF36 questionnaire was patient self-administered.
Timepoint [2] 328683 0
Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The value for Week 26 was derived by averaging values from Weeks 24 and 28.

Eligibility
Key inclusion criteria
a. Scheduled for SYNVISC ONE therapy.
b Male or female subjects, 30 to 90 years of age, inclusive.
c. Clinical history of symptomatic knee OA.
d. Radiographic evidence of knee OA. (Kellgren and Lawrence (K-L) Scale Grade I-III).
e. Fluent in English.
f. Willing and able to provide written informed consent.
g. Baseline pain score in study knee on a single VA global pain rating scale of between 35mm to 90mm (0-100mm scale).
Minimum age
30 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. History of gout or episodes of pseudogout in the study joint.
b. History of rheumatoid arthritis or psoriatic arthritis.
c. Kellgren and Lawrence Grade IV OA radiographs.
d. Previous treatment with viscosupplementation in the last six months.
e. Contraindications to SYNVISC ONE treatment as outlined in the product monograph.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The sample size of 130 enrolled patients, was based on the number of patients enrolled in the SYNVISC group (n=127), in a previously reported pharmaco-economics study [Raynauld JP et al. Osteoarthritis Cartilage. 2002;10(7):506-517; Torrance GW et al. Osteoarthritis Cartilage. 2002:10(7):518-527], which was sufficient to detect statistically significant clinically important improvements in the WOMAC Index, PGA, SF36 and HUI-3

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/02/2013
Date of last participant enrolment
Anticipated
Actual
30/04/2014
Date of last data collection
Anticipated
Actual
29/04/2015
Sample size
Target
130
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 294763 0
Commercial sector/Industry
Name [1] 294763 0
Sanofi Australia Pty Ltd
Country [1] 294763 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Medicine (The University of Queensland)
Herston Road
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 293609 0
None
Name [1] 293609 0
Address [1] 293609 0
Country [1] 293609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296170 0
Medical Research Ethics Committee
Ethics committee address [1] 296170 0
Medical Research Ethics Committee
The University of Queensland
St Lucia
QLD 4067
Ethics committee country [1] 296170 0
Australia
Date submitted for ethics approval [1] 296170 0
07/07/2011
Approval date [1] 296170 0
02/08/2011
Ethics approval number [1] 296170 0
201100070

Summary
Brief summary
Aims: The goals of the LOBRAS study, were: 1) To evaluate the group-level response to Synvisc-One in knee OA, using patient-centred measures of beneficial and adverse outcome; and 2) To evaluate response and state-attainment criteria and age-specific and gender-specific benchmarks, at the individual patient level, to assess the therapeutic response to Synvisc-One in knee OA.
Methods: The LOBRAS study involved a one year long multi-centre, pragmatic, “real-world” evaluation of the response to Synvisc-One, in 131 patients with knee OA. LOBRAS employed an open, quasi-experimental, one group, repeated measures design, and involved consented patients in Australia, fulfilling inclusion/exclusion criteria, and under the care of a medical specialist (Orthopaedic Surgeon, Rheumatologist, Sports and Exercise Medicine Physician), in routine clinical practice. Prior to, and for 52 weeks following, intra-articular Synvisc-One, patients were repeatedly evaluated, using the WOMAC NRS4.1 Index and the SF-36 questionnaire. The WOMAC NRS4.1 was administered by mobile phone (with paper back-up) at baseline, then once weekly for 12 weeks, and once every four weeks thereafter. The SF-36 was administered on paper, at baseline, then every four weeks thereafter. Patients were also monitored for adverse events.
Data Analyses:
The following analyses were pre-planned:
Effectiveness analyses:
Primary: Repeated measures analysis based on 26 week outcome for WOMAC pain, stiffness, function and total index scores, using continuous data.
Secondary: Repeated measures analysis based on 52 week outcome for WOMAC pain, stiffness, function and total index scores, using continuous data.

Responder analyses based on WOMAC pain, stiffness, function and total index scores, using categorical data.
a) OMERACT-OARSI Responder Criteria
b) Minimum Perceptible Clinical Improvement (MPCI)
c) Minimum Clinically Important Improvement (MCII 75)
d) WOMAC 20-50-70 Responder Criteria

State-attainment analyses based on WOMAC pain, stiffness, function and total index scores, using categorical data.
a) Bellamy Low Intensity Symptom State-attainment (BLISS) Index
b) WOMAC Age- and Gender-specific normative values
c) Patient Acceptable Symptom Severity (PASS 75)

Utility analysis using the WOMAC-HUI model for deriving HUI-3 utility values from WOMAC scores
Comparison of 26 week vs. 52 week outcomes for above analyses
Change in SF-36v2 (BL to week 26 and week 52)
Analysis of predictors of outcome at 26 weeks and 52 weeks including age, gender, BMI, KL Grade, Injection site, duration of OA, adverse events.
Time to re-injection in repeat treatment subgroup
Safety/Tolerability Analyses: Descriptive analysis of adverse events
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69850 0
Prof Nicholas Bellamy
Address 69850 0
The University of Queensland
School of Medicine
Royal Brisbane and Women's Hospital
Level 8, Health Sciences Building
Building 16/901
Herston
QLD 4029
Country 69850 0
Australia
Phone 69850 0
+61 7 3346 4825
Fax 69850 0
+61 7 3851 1559
Email 69850 0
[email protected]
Contact person for public queries
Name 69851 0
Nicholas Bellamy
Address 69851 0
School of Medicine
Royal Brisbane and Women's Hospital
Level 8, Health Sciences Building
Building 16/901
Herston
QLD 4029
Country 69851 0
Australia
Phone 69851 0
+61 7 3346 4825
Fax 69851 0
+61 7 3851 1559
Email 69851 0
[email protected]
Contact person for scientific queries
Name 69852 0
Nicholas Bellamy
Address 69852 0
School of Medicine
Royal Brisbane and Women's Hospital
Level 8, Health Sciences Building
Building 16/901
Herston
QLD 4029
Country 69852 0
Australia
Phone 69852 0
+61 7 3346 4825
Fax 69852 0
+61 7 3851 1559
Email 69852 0
[email protected]

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