CompletedNCT01934218Updated Mar 23, 2023Results posted

Gel-One Treatment in Knee Osteoarthritis

An interventional study of Gel-One and PBS in Osteoarthritis Knee, sponsored by Seikagaku Corporation. Completed at 41 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Seikagaku Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 814
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Osteoarthritis Knee

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Keywords

Knee
Osteoarthritis
Intra-articular injection

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 814 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Seikagaku Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 814 participants (actual)

Study arms

Active comparator
Gel-One
3 mL, a single intra-articular injection of Gel-One
Device: Gel-One
Placebo comparator
Phosphate Buffered Saline (PBS)
3 mL, a single intra-articular injection of PBS
Device: PBS

Interventions

DeviceGel-One
DevicePBS

What researchers measure

Primary outcomes

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.
Time frame: Baseline up to Week26

Results

Posted Jul 2, 2017

Participant flow

Double-blind Phase

Participant flow — Double-blind Phase
Milestone	Gel-One	Placebo
Started	404	410
Analyzed participants	402	407
Completed	356	356
Not completed	48	54
Withdrew: Adverse event	8	8
Withdrew: Lack of efficacy	6	7
Withdrew: Lost to follow-up	7	14
Withdrew: Physician decision	1	2
Withdrew: Protocol violation	4	0
Withdrew: Withdrawal by subject	16	13
Withdrew: Noncompliance with study protocol	5	8
Withdrew: Protocol violation of study eligibility	1	2

Open-Label Phase

Participant flow — Open-Label Phase
Milestone	Gel-One	Placebo
Started	316	328
Completed	290	304
Not completed	26	24
Withdrew: Adverse event	2	4
Withdrew: Lack of efficacy	1	4
Withdrew: Lost to follow-up	4	2
Withdrew: Physician decision	1	0
Withdrew: Protocol violation	1	0
Withdrew: Withdrawal by subject	13	11
Withdrew: Noncompliance with study protocol	4	2
Withdrew: Failure to exam primary evaluation	0	1

Outcome measures

PrimaryChange 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.

Time frame:: Baseline up to Week26
Reported as:: Mean · mm

Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
mm	Gel-One	Placebo
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26	-31.7 (-33.7 to -29.6)	-31.7 (-33.7 to -29.6)

Statistical analysis

Gel-One vs Placebo · Basic longitudinal model · p = 0.988 · Mean difference (final values): 0.0 · 95% CI -2.7 to 2.7

Post-hocChange From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at 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 to week 26 was calculated as baseline minus week 26.

Time frame:: Baseline and Week 26
Reported as:: Mean · mm

Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26
mm	Gel-One
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26	-29.5 (-32.1 to -26.9)

Statistical analysis

Gel-One ·

Adverse events

Collected over 25 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Gel-One	0/404 (0%)	7/404 (1.7%)	107/404 (26.5%)
Placebo	0/410 (0%)	6/410 (1.5%)	113/410 (27.6%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Gel-One	Placebo
ArthralgiaMusculoskeletal and connective tissue disorders	1/404	1/410
Joint effusionMusculoskeletal and connective tissue disorders	1/404	0/410
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/404	0/410
Oesophageal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/404	0/410
Coronary artery diseaseCardiac disorders	1/404	0/410
OsteomyelitisInfections and infestations	1/404	0/410
Deep vein thrombosisVascular disorders	1/404	0/410
Acute myocardial infarctionCardiac disorders	0/404	1/410
Aortic valve incompetenceCardiac disorders	0/404	1/410
Chest painGeneral disorders	0/404	1/410

Most frequent other events

Most frequent other events
Event	Gel-One	Placebo
ArthralgiaMusculoskeletal and connective tissue disorders	44/404	42/410
Joint swellingMusculoskeletal and connective tissue disorders	33/404	42/410
Joint effusionMusculoskeletal and connective tissue disorders	30/404	29/410

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Gel-One	Placebo	Total
Mean	59.3 ± 9.14	59.8 ± 9.32	59.6 ± 9.23

Sex: Female, Male
Sex: Female, Male(Participants)	Gel-One	Placebo	Total
Female	221	234	455
Male	181	173	354

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Gel-One	Placebo	Total
Hispanic or Latino	35	28	63
Not Hispanic or Latino	367	379	746
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Gel-One	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	52	52	104
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	93	70	163
White	247	277	524
More than one race	0	0	0
Unknown or Not Reported	10	7	17

Body mass index
Body mass index(kilograms / meter square)	Gel-One	Placebo	Total
Mean	28.597 ± 4.1923	28.797 ± 3.9244	28.698 ± 4.0585

Kellgren-Lawrence score
Kellgren-Lawrence score(participants)	Gel-One	Placebo	Total
1	113	111	224
2	161	164	325
3	128	132	260

osteoarthritis knee disease duration
osteoarthritis knee disease duration(years)	Gel-One	Placebo	Total
Mean	6.80 ± 7.835	6.90 ± 7.072	6.85 ± 7.456

Etiology
Etiology(participants)	Gel-One	Placebo	Total
Idiopathic	359	359	718
Post-traumatic	43	48	91

3 further baseline measures are reported on the registry.

Study locations

41 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01934218
Lead sponsor: Seikagaku Corporation
Collaborators: Zimmer Biomet
Responsible party: Sponsor
First posted: Sep 4, 2013
Start date: Aug 2013
Primary completion: Mar 2016
Completion: Mar 2016
Results posted: Jul 2, 2017
Last update: Mar 23, 2023

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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