Osteoarthritis Knee
Conditions
Keywords
Knee, Osteoarthritis, Intra-articular injection
Brief 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.
Sponsors
Zimmer Biomet
Seikagaku Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have a knee pain * Grade 1 to 3 on the Kellgren-Lawrence grading scale
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gel-One The participants received a single intra-articular injection of Gel-One. | 402 |
| Placebo The participants received a single intra-articular injection of PBS. | 407 |
| Total | 809 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Phase | Adverse Event | 8 | 8 |
| Double-blind Phase | Lack of Efficacy | 6 | 7 |
| Double-blind Phase | Lost to Follow-up | 7 | 14 |
| Double-blind Phase | Noncompliance with Study Protocol | 5 | 8 |
| Double-blind Phase | Physician Decision | 1 | 2 |
| Double-blind Phase | Protocol Violation | 4 | 0 |
| Double-blind Phase | Protocol Violation of Study Eligibility | 1 | 2 |
| Double-blind Phase | Withdrawal by Subject | 16 | 13 |
| Open-Label Phase | Adverse Event | 2 | 4 |
| Open-Label Phase | Failure to Exam Primary Evaluation | 0 | 1 |
| Open-Label Phase | Lack of Efficacy | 1 | 4 |
| Open-Label Phase | Lost to Follow-up | 4 | 2 |
| Open-Label Phase | Noncompliance with Study Protocol | 4 | 2 |
| Open-Label Phase | Physician Decision | 1 | 0 |
| Open-Label Phase | Protocol Violation | 1 | 0 |
| Open-Label Phase | Withdrawal by Subject | 13 | 11 |
Baseline characteristics
| Characteristic | Total | Gel-One | Placebo |
|---|---|---|---|
| 50-foot walk test contralateral VAS pain score | 11.73 mm STANDARD_DEVIATION 7.549 | 11.50 mm STANDARD_DEVIATION 7.536 | 11.95 mm STANDARD_DEVIATION 7.565 |
| 50-foot walk test VAS pain score | 69.31 mm STANDARD_DEVIATION 7.725 | 69.25 mm STANDARD_DEVIATION 7.64 | 69.36 mm STANDARD_DEVIATION 7.817 |
| Age, Continuous | 59.6 years STANDARD_DEVIATION 9.23 | 59.3 years STANDARD_DEVIATION 9.14 | 59.8 years STANDARD_DEVIATION 9.32 |
| Body mass index | 28.698 kilograms / meter square STANDARD_DEVIATION 4.0585 | 28.597 kilograms / meter square STANDARD_DEVIATION 4.1923 | 28.797 kilograms / meter square STANDARD_DEVIATION 3.9244 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 63 Participants | 35 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 746 Participants | 367 Participants | 379 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Etiology Idiopathic | 718 participants | 359 participants | 359 participants |
| Etiology Post-traumatic | 91 participants | 43 participants | 48 participants |
| Kellgren-Lawrence score 1 | 224 participants | 113 participants | 111 participants |
| Kellgren-Lawrence score 2 | 325 participants | 161 participants | 164 participants |
| Kellgren-Lawrence score 3 | 260 participants | 128 participants | 132 participants |
| osteoarthritis knee disease duration | 6.85 years STANDARD_DEVIATION 7.456 | 6.80 years STANDARD_DEVIATION 7.835 | 6.90 years STANDARD_DEVIATION 7.072 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 104 Participants | 52 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 163 Participants | 93 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) White | 524 Participants | 247 Participants | 277 Participants |
| Sex: Female, Male Female | 455 Participants | 221 Participants | 234 Participants |
| Sex: Female, Male Male | 354 Participants | 181 Participants | 173 Participants |
| Study knee Left | 388 participants | 193 participants | 195 participants |
| Study knee Right | 421 participants | 209 participants | 212 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 404 | 0 / 410 |
| other Total, other adverse events | 107 / 404 | 113 / 410 |
| serious Total, serious adverse events | 7 / 404 | 6 / 410 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gel-One | Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 | -31.7 mm |
| Placebo | Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 | -31.7 mm |
p-value: 0.98895% CI: [-2.7, 2.7]Basic longitudinal model
Post Hoc
Change 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
Population: The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gel-One | Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26 | -29.5 mm |
Comparison: A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.