Combining two Hyaluronic Acids with different characteristics: a randomised, double-blind, placebo controlled trial
| ISRCTN | ISRCTN98630331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98630331 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/10/2007
- Registration date
- 30/10/2007
- Last edited
- 28/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Petrella
Scientific
Scientific
801 Commissioners Road
Suite 3002
London
N6C 5J1
Canada
Study information
| Study design | Randomised, placebo-controlled, double-blind prospective design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | 2 HAs |
| Study objectives | Combined Hyaluronic Acids (HA) will improve clinical outcomes more than a single HA. |
| Ethics approval(s) | Ethics approval received from the Research Ethics Board of the University of Western Ontario on the 10th September 2006 (ref: # 166732). |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee |
| Intervention | 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 concentrations (DMW) 4. Saline placebo Physicians and patients were blinded to assignment (syringes were covered to conceal any details of product or volume). Low molecular weight solution of HA was a marketed product of 0.50 - 0.73 x 10^6 Daltons and the high molecular weight HA was a marketed product of 6 million kDa, both indicated for intra-articular injection for knee osteoarthritis. 2 ml of LMW and HMW were injected using an aseptic technique and a medial approach. No anaesthetic was used either topically or intra-articularly. Each injection was performed one week apart (± 2 days) by an experienced clinician. All injections were initiated after baseline and follow-up assessments of Visual Analogue Scale (VAS) and global satisfaction which were performed by an independent technician. The DMW preparation consisted of 0.7 ml of sterile 2.2% LMW (0.58 - 0.78 x 10^6 Daltons) sodium hyaluronate and 0.7 ml of sterile 1% HMW (1.2 - 2.0 x 10^6 Daltons) sodium hyaluronate. Viscoelastics were separated by a Debiopass stopper within a pre-filled 3 ml sterile syringe. Injection was conducted as for the LMW and HMW preparations as described above. Patients were free to seek additional therapeutic modalities including physical therapy and analgesics (including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]) but not intra-articular therapies prior to their presentation for follow-up. All concomitant treatments were recorded. All assessments were conducted at baseline V1, and prior to each injection at visits 2, 3 and 4, and follow-up visits at 4 (V5), 12 (V6) and 16 (V7) weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hyaluronic Acid |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/01/2007 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
801 Commissioners Road
London
N6C 5J1
Canada
N6C 5J1
Canada
Sponsor information
Lawson Health Research Institute (Canada)
Research organisation
Research organisation
801 Commissioners Road East
London
Ontario
N6C 5J1
Canada
| Website | http://www.lhrionhealth.ca |
|---|---|
"ROR" |
https://ror.org/051gsh239 |
Funders
Funder type
Research organisation
Lawson Health Research Institute (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2008 | Yes | No |
