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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]

None

Universal Trial Number (UTN)

Trial acronym

LOBRAS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis (Knee)

Condition category

Condition code

Musculoskeletal

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

26 weeks post SYNVISC-ONE procedure

Secondary outcome [1]

OA symptom severity assessed using the WOMAC Index. The WOMAC Index questionnaire was patient self-administered.

Timepoint [1]

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]

Health related quality of life assessed by SF36. The SF36 questionnaire was patient self-administered.

Timepoint [2]

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?

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]

Commercial sector/Industry

Name [1]

Sanofi Australia Pty Ltd

Address [1]

12-24 Talavera Rd
Macquarie Park
NSW 2113

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research Ethics Committee

Ethics committee address [1]

Medical Research Ethics Committee
The University of Queensland
St Lucia 
QLD 4067

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/07/2011

Approval date [1]

02/08/2011

Ethics approval number [1]

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

Prof Nicholas Bellamy

Address

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

Australia

Phone

+61 7 3346 4825

Fax

+61 7 3851 1559

[email protected]

Contact person for public queries

Name

Nicholas Bellamy

Address

School of Medicine
Royal Brisbane and Women's Hospital
Level 8, Health Sciences Building
Building 16/901
Herston
QLD 4029

Country

Australia

Phone

+61 7 3346 4825

Fax

+61 7 3851 1559

[email protected]

Contact person for scientific queries

Name

Nicholas Bellamy

Address

School of Medicine
Royal Brisbane and Women's Hospital
Level 8, Health Sciences Building
Building 16/901
Herston
QLD 4029

Country

Australia

Phone

+61 7 3346 4825

Fax

+61 7 3851 1559

[email protected]

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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