Condition category
Musculoskeletal Diseases
Date applied
23/10/2007
Date assigned
30/10/2007
Last edited
28/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Petrella

ORCID ID

Contact details

801 Commissioners Road
Suite 3002
London
N6C 5J1
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

2 HAs

Study hypothesis

Combined Hyaluronic Acids (HA) will improve clinical outcomes more than a single HA.

Ethics approval

Ethics approval received from the Research Ethics Board of the University of Western Ontario on the 10th September 2006 (ref: # 166732).

Study design

Randomised, placebo-controlled, double-blind prospective design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Hyaluronic Acid

Primary outcome measures

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 trial start date

01/01/2007

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/01/2007

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Canada

Trial participating centre

801 Commissioners Road
London
N6C 5J1
Canada

Sponsor information

Organisation

Lawson Health Research Institute (Canada)

Sponsor details

801 Commissioners Road East
London
Ontario
N6C 5J1
Canada

Sponsor type

Research organisation

Website

http://www.lhrionhealth.ca

Funders

Funder type

Research organisation

Funder name

Lawson Health Research Institute (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18204873

Publication citations

  1. Results

    Petrella RJ, Cogliano A, Decaria J, Combining two hyaluronic acids in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial., Clin. Rheumatol., 2008, 27, 8, 975-981, doi: 10.1007/s10067-007-0834-4.

Additional files

Editorial Notes