Osteoarthritis, KneeNCT01132677
A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis
A study testing Hylan G-F 20 (Synvisc One) and Methylprednisolone (Corticosteroid) in people with Osteoarthritis, Knee, run by LifeMark Health at 1 site in Canada.
Trial summary
Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection? Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hylan G-F 20 (Synvisc One) and Methylprednisolone (Corticosteroid)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Dec 2011
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical
- 19-75 years of age (inclusive)
- Symptomatic OA (1 of the following: pain, stiffness, or swelling)
- Evidence of grade I, II or III OA on radiographic images according to Kellgren-Lawrence grading scale.
Who cannot join
- Clinical
- Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy)
- Intra-articular treatment within the last 3 months
- Ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity
- Inflamed knee or pronounced effusion
- Allergy to birds, eggs, avian proteins or known HA or corticosteroid
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- Venous or lymphatic stasis
- Skin condition in the injection area
- Evidence of infection in the affected joint
- History of crystalline arthropathy or inflammatory arthritis
- Pregnant or nursing
- Third Party, Medical Legal or Workers' Compensation Board
- Patient unable to understand English or unable to providing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis
Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?
Read the detailed description
OBJECTIVES
Primary i. To determine if patients' VAS "pain while walking" is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for treatment of knee OA.
Secondary i. To determine if differences in VAS "pain while walking" scores exist at 1 and 3 weeks, and 3 and 6 months post injection between MPA and HA patients.
ii. To determine if differences in VAS "pain at rest" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.
iii. To determine if differences in VAS "pain with stairs" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.
iii. To determine if differences in KOOS questionnaire scores exist at 6 weeks, 3 months and 6 months post injection between MPA and HA patients.
iv. To determine if differences in WOMAC questionnaire scores exist at 6 weeks, 3 months, and 6 months post injection between MPA and HA patients.
- To determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6 months post injection between MPA and HA patients. vi. To track the number of patients who receive additional injections after 3 months following their index injection.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hylan G-F 20 (Synvisc One), Methylprednisolone (Corticosteroid)
- Keywords
- OA of Knee, Osteoarthritis of Knee, Viscosupplementation and Osteoarthritis, Viscosupplementation and OA, Hyaluronic Acid, Corticosteroid injection versus hyaluronic acid, Synvisc One and Knee OA, viscosupplementation and knee pain, knee Pain from OA
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20 (Synvisc One)Device
Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
Methylprednisolone (Corticosteroid)Drug
Single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid (HA) Injection | Active comparator | Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed. Receives: Device: Hylan G-F 20 (Synvisc One) |
| Corticosteroid Injection | Active comparator | Patients allocated to the corticosteroid injection will receive a single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. Aspiration of the knee will not be performed. Receives: Drug: Methylprednisolone (Corticosteroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).
As described in title
Measured: VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.
Secondary outcomes (1)
Pain at rest or with stairs as reported byu the patient on a VAS
Secondary Outcomes:
- "Pain at rest" and "pain with stairs" as reported by the patient on a VAS (Additional outcomes ii. Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a valid, reliable and responsive questionnaire that is self-administered and consists of 5 subscales. iii. The KOOS includes the WOMAC Osteoarthritis Index LK 3.0 and thus, WOMAC scores will also be computed. iv. Adverse events as reviewed and documented by the physician v. The number of subsequent re-injections or treatment strategies.)
Measured: Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeMark Health
- Sponsor type
- University, hospital or other
- Investigators
- Brad J Monteleone, Physician, Principal investigator, UBC - Department of Family Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132677
- Sponsor's protocol ID
- HA-CS-OA1
- Status last verified
- Feb 2010
- First submitted
- 27 May 2010
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01132677
- Acronym / sponsor ID
- HA-CS-OA1
- Conditions
- Osteoarthritis, Knee
- Keywords
- OA of Knee, Osteoarthritis of Knee, Viscosupplementation and Osteoarthritis, Viscosupplementation and OA, Hyaluronic Acid, Corticosteroid injection versus hyaluronic acid, Synvisc One and Knee OA, viscosupplementation and knee pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- LifeMark HealthUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 28 May 2010 (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.
Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?
Detailed description
OBJECTIVES
Primary i. To determine if patients' VAS "pain while walking" is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for treatment of knee OA.
Secondary i. To determine if differences in VAS "pain while walking" scores exist at 1 and 3 weeks, and 3 and 6 months post injection between MPA and HA patients.
ii. To determine if differences in VAS "pain at rest" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.
iii. To determine if differences in VAS "pain with stairs" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.
iii. To determine if differences in KOOS questionnaire scores exist at 6 weeks, 3 months and 6 months post injection between MPA and HA patients.
iv. To determine if differences in WOMAC questionnaire scores exist at 6 weeks, 3 months, and 6 months post injection between MPA and HA patients.
- To determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6 months post injection between MPA and HA patients. vi. To track the number of patients who receive additional injections after 3 months following their index injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid (HA) Injection | Active comparator | Device: Hylan G-F 20 (Synvisc One)Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed. |
| Corticosteroid Injection | Active comparator | Drug: Methylprednisolone (Corticosteroid)Patients allocated to the corticosteroid injection will receive a single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. Aspiration of the knee will not be performed. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical
Key exclusion criteria (13 listed)
- Clinical
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 |
|---|---|---|
| Hylan G-F 20 (Synvisc One)Single IA injection of 6cc's. Injections will be administered as outlined on the company label. | Device | Hyaluronic Acid (HA) Injection |
| Methylprednisolone (Corticosteroid)Single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label. | Drug | Corticosteroid Injection |
Primary outcome
The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).
Time frame: VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.
As described in title
1 secondary outcome
Pain at rest or with stairs as reported byu the patient on a VAS
Time frame: Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
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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.
Brad J Monteleone, Physician principal investigator
UBC - Department of Family Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hylan G-F 20 (Synvisc One) and Methylprednisolone (Corticosteroid) in people with Osteoarthritis, Knee, run by LifeMark Health 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 4 inclusion and 13 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 28 May 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible). (time frame: VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2010.