CompletedNCT02110238Updated Mar 9, 2021Results posted

Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA

An interventional study of Supartz and Euflexxa in Osteoarthritis, sponsored by Bioventus LLC. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-09.

Sponsored by Bioventus LLC · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 421
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study summary

The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.

Read the detailed description

The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12.

Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.

Conditions studied

Osteoarthritis

Browse trials for

Osteoarthritis 4,398

Keywords

osteoarthritis
knee pain
Supartz
Euflexxa
HA
hyaluronic acid

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 421 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Bioventus LLC is the lead sponsor of 14 studies on the registry; 1 is 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

Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria.
Symptoms in study knee for at least one year prior to the screening visit
Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity.
Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.

Exclusion criteria

Exclusion Criteria:

Inability to perform a 50 foot walk test.
Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections.
Prior hyaluronic acid injections into the study knee within six months of the screening visit.
Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit.
Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
Subjects with clinically diagnosed symptomatic OA of the hip.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 421 participants (actual)

Study arms

Active comparator
Euflexxa
Euflexxa® (hyaluronic acid of bacterial origin)
Device: Euflexxa
Experimental
Supartz
SUPARTZ® (hyaluronic acid of avian origin)
Device: Supartz

Interventions

DeviceSupartz
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
DeviceEuflexxa
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.

What researchers measure

Primary outcomes

WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.
Time frame: Change from Baseline (CFB) over Weeks 3, 6, and 12

Results

Posted Jun 23, 2016

Participant flow

29 outpatient medical clinics enrolled subjects over 4.5 months

12 Week Pivotal Phase

Participant flow — 12 Week Pivotal Phase
Milestone	Euflexxa	Supartz
Started	212	209
Completed	202	200
Not completed	10	9
Withdrew: Adverse event	3	0
Withdrew: Lack of efficacy	2	3
Withdrew: Lost to follow-up	2	0
Withdrew: Physician decision	0	2
Withdrew: Protocol violation	0	1
Withdrew: Withdrawal by subject	3	3

14 Week Blinded Extension Phase

Participant flow — 14 Week Blinded Extension Phase
Milestone	Euflexxa	Supartz
Started	202	200
Completed	190	188
Not completed	12	12
Withdrew: Adverse event	1	1
Withdrew: Lack of efficacy	2	4
Withdrew: Lost to follow-up	3	1
Withdrew: Protocol violation	2	3
Withdrew: Withdrawal by subject	4	3

Outcome measures

PrimaryWOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.

Time frame:: Change from Baseline (CFB) over Weeks 3, 6, and 12
Reported as:: Least squares mean · millimeter

WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
millimeter	Euflexxa	Supartz
WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline	30.15 (27.59 to 32.71)	26.85 (24.35 to 29.35)

Statistical analysis

Euflexxa vs Supartz · Least square mean difference: -3.30 · 95% CI -6.77 to 0.17A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 "single point estimate" least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated.

Adverse events

Collected over 26 Weeks (12 week primary period plus 14 week extension phase). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Euflexxa	—	6/211 (2.8%)	59/211 (28%)
Supartz	—	1/209 (0.5%)	60/209 (28.7%)

Most frequent serious events

Most frequent serious events
Event	Euflexxa	Supartz
CholelithiasisHepatobiliary disorders	0/211	1/209
Myocardial infarctionCardiac disorders	1/211	0/209
Internal herniaGastrointestinal disorders	1/211	0/209
Acute sinusitisInfections and infestations	1/211	0/209
Pneumothorax tramaticInjury, poisoning and procedural complications	1/211	0/209
NephrolithiasisRenal and urinary disorders	1/211	0/209
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	1/211	0/209

Most frequent other events

Most frequent other events
Event	Euflexxa	Supartz
HeadacheNervous system disorders	25/211	22/209
ArthralgiaMusculoskeletal and connective tissue disorders	24/211	23/209
Back painMusculoskeletal and connective tissue disorders	10/211	15/209

Baseline characteristics

All but 1 subject who discontinued after being randomized to Euflexxa but unable to tolerate the injection procedure. This subject did not receive any of the study device via injection.

Age, Continuous
Age, Continuous(years)	Euflexxa	Supartz	Total
Mean	60.9 ± 9.33	59.3 ± 9.30	60.1 ± 9.34

Sex: Female, Male
Sex: Female, Male(Participants)	Euflexxa	Supartz	Total
Female	135	138	273
Male	76	71	147

Study locations

1 site

Triangle Orthopaedic Associates
Durham, North Carolina 27704, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02110238
Lead sponsor: Bioventus LLC
Collaborators: Seikagaku Corporation
Responsible party: Sponsor
First posted: Apr 10, 2014
Start date: Mar 2014
Primary completion: Nov 2014
Completion: Feb 2015
Results posted: Jun 23, 2016
Last update: Mar 9, 2021

Study contacts

Vibeke Strand, MD

principal investigator · Stanford University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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