None listed
Conditions
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
Interventions
Participants received a single 6ml intra-articular SYNVISC-ONE, and were followed for the next 52 weeks
Sponsors
The University of Queensland
Eligibility
Sex/Gender
All
Age
30 Years to 90 Years
Healthy volunteers
No
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).
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.
Outcome results
None listed