Osteoarthritis KneeNCT01934218

Gel-One Treatment in Knee Osteoarthritis

A study testing Gel-One and PBS in people with Osteoarthritis Knee, run by Seikagaku Corporation at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis Knee
What is being tested?: Gel-One and PBS
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 814 participants
Where: 41 sitesUnited States
Study dates: Aug 2013to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a knee pain
Grade 1 to 3 on the Kellgren-Lawrence grading scale

Who cannot join

BMI greater than 35 kg/m2
Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
Had a joint replacement of the target knee

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Study site
Altoona, Pennsylvania
Study site
Anaheim, California
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Austin, Texas
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Bedford, Texas
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Birmingham, Alabama
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Boulder, Colorado
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Cerritos, California
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Charlottesville, Virginia
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Cincinnati, Ohio
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Cos Cob, Connecticut
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Costa Mesa, California
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Duncansville, Pennsylvania
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Englewood, Colorado
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Garden Grove, California
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Hartsdale, New York
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High Point, North Carolina
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Lake Charles, Louisiana
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Marietta, Georgia
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Morton Grove, Illinois
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New York, New York
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Newton, Kansas
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North Hollywood, California
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Oklahoma City, Oklahoma
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Oviedo, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pinellas Park, Florida
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Plantation, Florida
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Raleigh, North Carolina
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San Diego, California
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Sarasota, Florida
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Sheffield, Alabama
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St Louis, Missouri
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State College, Pennsylvania
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Tamarac, Florida
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Tampa, Florida
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Trenton, New Jersey
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Trumbull, Connecticut
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Tucson, Arizona
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Wheaton, Maryland
Study site
Wichita, Kansas

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Conditions: Osteoarthritis Knee
Being tested: Gel-One, PBS
Keywords: Knee, Osteoarthritis, Intra-articular injection
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.

Gel-OneDevice
PBSDevice

Study groups in NCT01934218
Study group	Role	What they receive
Gel-One	Active comparator	3 mL, a single intra-articular injection of Gel-One Receives: Device: Gel-One
Phosphate Buffered Saline (PBS)	Placebo comparator	3 mL, a single intra-articular injection of PBS Receives: Device: PBS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.
Measured: Baseline up to Week26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Mar 2016

First posted4 Sep 2013 (estimated)
Study startAug 2013
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 814 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01934218
Sponsor's protocol ID: Gel/1133
Status last verified: Mar 2023
First submitted: 29 Aug 2013
Last updated: 23 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Takamura J, Seo T, Strand V. A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Cartilage. 2019 Oct;10(4):417-422. doi: 10.1177/1947603518768015. Epub 2018 Apr 12.
PubMed 29644875

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Osteoarthritis Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension
ClinicalTrials.gov ID: NCT01934218
Acronym / sponsor ID: Gel/1133
Conditions: Osteoarthritis Knee
Keywords: Knee, Osteoarthritis, Intra-articular injection
Study type: Interventional
Recruitment status: Completed
Enrolment: 814 participants (actual)
Lead sponsor: Seikagaku CorporationIndustry (pharma, biotech, devices)
Collaborators: Zimmer Biomet
Study start: Aug 2013
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 4 Sep 2013 (estimated)
Results: Posted 2 Jul 2017

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 whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Gel-One	Active comparator	Device: Gel-One3 mL, a single intra-articular injection of Gel-One
Phosphate Buffered Saline (PBS)	Placebo comparator	Device: PBS3 mL, a single intra-articular injection of PBS

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Have a knee pain
Grade 1 to 3 on the Kellgren-Lawrence grading scale

Key exclusion criteria (3 listed)

BMI greater than 35 kg/m2
Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
Had a joint replacement of the target knee

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
Gel-One	Device	Gel-One
PBS	Device	Phosphate Buffered Saline (PBS)

Primary outcome

Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
Time frame: Baseline up to Week26
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.

Results and safety

Results posted to the registry on 2 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gel-One	404	356
Placebo	410	356

Primary outcome: Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26

Time frame: Baseline up to Week26. Mean (95% Confidence Interval). Unit: mm

Measure	Gel-One n = 402	Placebo n = 407
Value	-31.7 (-33.7 to -29.6)	-31.7 (-33.7 to -29.6)

Gel-One vs Placebo: Mean Difference (Final Values): 0.0 (95% CI -2.7 to 2.7), p = 0.988, Basic longitudinal model

Adverse events

Time frame: 25 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gel-One	7 of 404 (1.7%)	107 of 404 (26.5%)	0 of 404
Placebo	6 of 410 (1.5%)	113 of 410 (27.6%)	0 of 410

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29644875Takamura J, Seo T, Strand V. A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Cartilage. 2019 Oct;10(4):417-422. doi: 10.1177/1947603518768015. Epub 2018 Apr 12.

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.

The record lists no contact. Use the official record to reach the sponsor.

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gel-One and PBS in people with Osteoarthritis Knee, run by Seikagaku Corporation at 41 sites in United States.

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 2 inclusion and 3 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 (time frame: Baseline up to Week26). 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 NCT01934218, 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 23 Mar 2023.