Osteoarthritis, KneePhase 4NCT00778076
The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics
A Phase 4 study testing Hyaluronic acid in people with Osteoarthritis, Knee, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 - 80 years old.
- Mild to moderate knee osteoarthritis:
- Clinical diagnosis (symptoms).
- Radiographic diagnosis (Kellgren-Lawrence grade I - III).
- Must provide provide informed consent and knowledge of all possible benefits and possible adverse events.
- Available for duration of the study.
- Not taking any other knee osteoarthritis medications during the study.
Who cannot join
- Non - OA arthritides.
- Hip, ankle, or foot OA.
- End stage OA.
- Lower back/extremity pathology.
- Previous surgery on knee affected by OA (except arthroscopy within the past 12 - 18 months).
- Neurological/Cardiovascular gait impairment.
Show all 12Show fewer
- Pregnant.
- Cognitively impaired.
- Not available for duration of study.
- Taking other knee OA medications at time of study.
- Gastro-intestinal disturbance.
- Avian allergy or any other contraindication to intra-articular injections with Hyaluronic acid.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center
London, Ontario, N6C 5J1
About this study
Official title: The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study
The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than that of a placebo injection, and to observe whether HA's viscoelastic properties are manifested in a human knee OA population. We hypothesize that HA injections will relieve pain to a greater extent than placebo injections in knee OA patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.
Read the detailed description
Knee osteoarthritis (OA) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. Hyaluronic acid (HA) injections are incorporated into non-surgical standard of care for knee OA patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee OA interventions. HA allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of HA treatment in knee OA patients, these properties have yet to be proven in a controlled clinical trial setting. Therefore, we are undertaking this study to observe whether the physiological adaptation in the OA knee joint, initiated by HA injection, will result in biomechanical improvements in human knee OA patients, specifically walking mechanics.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hyaluronic acid, Placebo (Saline injection)
- Keywords
- Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDevice
Also called Suplasyn, Sodium Hyaluronate
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
Placebo (Saline injection)Device
Also called Sham injection, Saline injection
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
| Study group | Role | What they receive |
|---|---|---|
| HAG | Active comparator | Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart. Receives: Device: Hyaluronic acid |
| PG | Placebo comparator | Those patients that receive 3 consecutive placebo injections one week apart. Receives: Device: Placebo (Saline injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis with GAITRite software.
Measured: Baseline; after each injection; 3 and 6 months post treatment.
Secondary outcomes (1)
WOMAC OA index (pain, stiffness, function); Six minute walk test (function).
Measured: Baseline; after each injection; 3 and 6 months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Robert J Petrella, MD, PhD, Principal investigator, The University of Western OntarioJoseph E DeCaria, BA, MSc('09), Study director, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778076
- Sponsor's protocol ID
- REB#: 14017
- Status last verified
- Mar 2009
- First submitted
- 22 Oct 2008
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang SF, Chen CP, Chen MJ, Pei YC, Lau YC, Leong CP. Changes in sagittal ground reaction forces after intra-articular hyaluronate injections for knee osteoarthritis. Arch Phys Med Rehabil. 2004 Jun;85(6):951-5. doi: 10.1016/j.apmr.2003.08.095.
PubMed 15179649DeCaria JE, Montero-Odasso M, Wolfe D, Chesworth BM, Petrella RJ. The effect of intra-articular hyaluronic acid treatment on gait velocity in older knee osteoarthritis patients: a randomized, controlled study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):310-5. doi: 10.1016/j.archger.2011.11.007. Epub 2011 Dec 9.
PubMed 22169699
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00778076
- Acronym / sponsor ID
- REB#: 14017
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than that of a placebo injection, and to observe whether HA's viscoelastic properties are manifested in a human knee OA population. We hypothesize that HA injections will relieve pain to a greater extent than placebo injections in knee OA patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.
Detailed description
Knee osteoarthritis (OA) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. Hyaluronic acid (HA) injections are incorporated into non-surgical standard of care for knee OA patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee OA interventions. HA allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of HA treatment in knee OA patients, these properties have yet to be proven in a controlled clinical trial setting. Therefore, we are undertaking this study to observe whether the physiological adaptation in the OA knee joint, initiated by HA injection, will result in biomechanical improvements in human knee OA patients, specifically walking mechanics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAG | Active comparator | Device: Hyaluronic acidPatients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart. |
| PG | Placebo comparator | Device: Placebo (Saline injection)Those patients that receive 3 consecutive placebo injections one week apart. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 - 80 years old.
- Mild to moderate knee osteoarthritis:
- Clinical diagnosis (symptoms).
- Radiographic diagnosis (Kellgren-Lawrence grade I - III).
- Must provide provide informed consent and knowledge of all possible benefits and possible adverse events.
Key exclusion criteria (12 listed)
- Non - OA arthritides.
- Hip, ankle, or foot OA.
- End stage OA.
- Lower back/extremity pathology.
- Previous surgery on knee affected by OA (except arthroscopy within the past 12 - 18 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acidAlso: Suplasyn, Sodium Hyaluronate3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid. | Device | HAG |
| Placebo (Saline injection)Also: Sham injection, Saline injection3 consecutive injections, each one week apart, of 20mg/2ml of Placebo. | Device | PG |
Primary outcome
Gait analysis with GAITRite software.
Time frame: Baseline; after each injection; 3 and 6 months post treatment.
1 secondary outcome
WOMAC OA index (pain, stiffness, function); Six minute walk test (function).
Time frame: Baseline; after each injection; 3 and 6 months post treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Background: PubMed 15179649Tang SF, Chen CP, Chen MJ, Pei YC, Lau YC, Leong CP. Changes in sagittal ground reaction forces after intra-articular hyaluronate injections for knee osteoarthritis. Arch Phys Med Rehabil. 2004 Jun;85(6):951-5. doi: 10.1016/j.apmr.2003.08.095.
- Derived from this study: PubMed 22169699DeCaria JE, Montero-Odasso M, Wolfe D, Chesworth BM, Petrella RJ. The effect of intra-articular hyaluronic acid treatment on gait velocity in older knee osteoarthritis patients: a randomized, controlled study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):310-5. doi: 10.1016/j.archger.2011.11.007. Epub 2011 Dec 9.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Petrella, MD, PhD principal investigator
The University of Western Ontario
Joseph E DeCaria, BA, MSc('09) study director
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid in people with Osteoarthritis, Knee, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait analysis with GAITRite software. (time frame: Baseline; after each injection; 3 and 6 months post treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00778076, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.