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Combining two Hyaluronic Acids with different characteristics: a randomised, double-blind, placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98630331
Enrollment
200
Registered
2007-10-30
Start date
2007-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee Musculoskeletal Diseases Osteoarthritis

Interventions

Patients were randomised to receive one of four treatments: 1. Lower Molecular Weight HA (LMW) 2. Higher Molecular Weight HA (HMW) 3. Combined lower and higher molecular weight and different concentr

Sponsors

Lawson Health Research Institute (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Radiographic evidence of grade 1 to 3 medial compartment Osteoarthritis (OA) 2. Did not exhibit non-arthritis related disease 3. Gave consent as approved by the University of Western Ontario Ethics Review Board 4. Age range at recruitment was 45 - 85 years, both men and women

Exclusion criteria

Exclusion criteria: 1. Previous injection with HA or corticosteroids 2. Bilateral knee OA 3. Unstable cardiovascular or metabolic disease 4. Unable to commit to follow-up period

Design outcomes

Primary

MeasureTime frame
Improvement in self-paced 40-m walking pain using the Visual Analogue Scale (VAS), measured at V1 - V7. Timepoints: V1 = Baseline V2 = Week 1 V3 = Week 2 V4 = Week 3 V5 = Week 4 V6 = Week 12 V7 = Week 16

Secondary

MeasureTime frame
1. Improvement in seated rest pain Visual Analogue Scale (VAS), measured at V1 - V7 2. Patient global satisfaction using a 5-point numerical scale, with 1 representing not satisfied and 5 completely satisfied, measured at V1 - V7 3. Presence of adverse events and concomitant medications, measured at V1 - V7 Timepoints: V1 = Baseline V2 = Week 1 V3 = Week 2 V4 = Week 3 V5 = Week 4 V6 = Week 12 V7 = Week 16

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026