Osteoarthritis of the KneePhase 2NCT01134406
Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)
A Phase 2 study testing Hydros Joint Therapy, Hydros-TA Joint Therapy and Synvisc-One in people with Osteoarthritis of the Knee, run by Carbylan Therapeutics, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Hydros Joint Therapy, Hydros-TA Joint Therapy and Synvisc-One
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Oct 2011
- Phase
- Phase 2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.
Who cannot join
- Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- Generalized symptomatic OA in lower extremity joints other than the knees.
- Active infection in either knee joint or adjacent tissues.
- Any contraindications for intra-articular injection or aspiration.
- Knee surgery or trauma within 3 months prior to enrollment.
- Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment.
- Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.
- Body Mass Index (BMI) greater than 35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros-TA Joint Therapy for Management of Pain Associated With Osteoarthritis in the Knee
The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
Read the detailed description
The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.
The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Hydros Joint Therapy, Hydros-TA Joint Therapy, Synvisc-One
- Keywords
- Osteoarthritis, knee
- 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.
Hydros Joint TherapyDevice
Also called Hydros
Single intra-articular injection.
Hydros-TA Joint TherapyDevice
Also called Hydros-TA
Single intra-articular injection
Synvisc-OneDevice
Also called Hylan G-F 20
Single intra-articular injection.
| Study group | Role | What they receive |
|---|---|---|
| Hydros Joint Therapy | Experimental | Experimental viscosupplement. Receives: Device: Hydros Joint Therapy |
| Hydros-TA Joint Therapy | Experimental | Experimental viscosupplement. Receives: Device: Hydros-TA Joint Therapy |
| Synvisc-One | Active comparator | Commercial control. Receives: Device: Synvisc-One |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC VAS Pain over 26 weeks
Measured: 26 weeks post treatment
Secondary outcomes (1)
WOMAC VAS Stiffness and Function over 26 weeks
Measured: 26 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carbylan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134406
- Sponsor's protocol ID
- COR 1.0
- Status last verified
- Nov 2011
- First submitted
- 5 May 2010
- Last updated
- 3 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. doi: 10.1186/s12891-015-0513-6.
PubMed 25887932
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros-TA Joint Therapy for Management of Pain Associated With Osteoarthritis in the Knee
- ClinicalTrials.gov ID
- NCT01134406
- Acronym / sponsor ID
- COR 1.0
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Carbylan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
Detailed description
The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.
The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydros Joint Therapy | Experimental | Device: Hydros Joint TherapyExperimental viscosupplement. |
| Hydros-TA Joint Therapy | Experimental | Device: Hydros-TA Joint TherapyExperimental viscosupplement. |
| Synvisc-One | Active comparator | Device: Synvisc-OneCommercial control. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.
Key exclusion criteria (8 listed)
- Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- Generalized symptomatic OA in lower extremity joints other than the knees.
- Active infection in either knee joint or adjacent tissues.
- Any contraindications for intra-articular injection or aspiration.
- Knee surgery or trauma within 3 months prior to enrollment.
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 |
|---|---|---|
| Hydros Joint TherapyAlso: HydrosSingle intra-articular injection. | Device | Hydros Joint Therapy |
| Hydros-TA Joint TherapyAlso: Hydros-TASingle intra-articular injection | Device | Hydros-TA Joint Therapy |
| Synvisc-OneAlso: Hylan G-F 20Single intra-articular injection. | Device | Synvisc-One |
Primary outcome
WOMAC VAS Pain over 26 weeks
Time frame: 26 weeks post treatment
1 secondary outcome
WOMAC VAS Stiffness and Function over 26 weeks
Time frame: 26 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2011.
- Derived from this study: PubMed 25887932Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. doi: 10.1186/s12891-015-0513-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydros Joint Therapy, Hydros-TA Joint Therapy and Synvisc-One in people with Osteoarthritis of the Knee, run by Carbylan Therapeutics, Inc. 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 3 Nov 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC VAS Pain over 26 weeks (time frame: 26 weeks 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 NCT01134406, which also lists 1 linked publication.
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 3 Nov 2011.