Trial Outcomes & Findings for Gel-One Treatment in Knee Osteoarthritis (NCT NCT01934218)
NCT ID: NCT01934218
Last Updated: 2023-03-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
814 participants
Primary outcome timeframe
Baseline up to Week26
Results posted on
2023-03-23
Participant Flow
Participant milestones
| Measure |
Gel-One
The participants received a single intra-articular injection of Gel-One.
|
Placebo
The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS).
|
|---|---|---|
|
Double-blind Phase
STARTED
|
404
|
410
|
|
Double-blind Phase
Analyzed Participants
|
402
|
407
|
|
Double-blind Phase
COMPLETED
|
356
|
356
|
|
Double-blind Phase
NOT COMPLETED
|
48
|
54
|
|
Open-Label Phase
STARTED
|
316
|
328
|
|
Open-Label Phase
COMPLETED
|
290
|
304
|
|
Open-Label Phase
NOT COMPLETED
|
26
|
24
|
Reasons for withdrawal
| Measure |
Gel-One
The participants received a single intra-articular injection of Gel-One.
|
Placebo
The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS).
|
|---|---|---|
|
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
Physician Decision
|
1
|
2
|
|
Double-blind Phase
Protocol Violation
|
4
|
0
|
|
Double-blind Phase
Withdrawal by Subject
|
16
|
13
|
|
Double-blind Phase
Noncompliance with Study Protocol
|
5
|
8
|
|
Double-blind Phase
Protocol Violation of Study Eligibility
|
1
|
2
|
|
Open-Label Phase
Adverse Event
|
2
|
4
|
|
Open-Label Phase
Lack of Efficacy
|
1
|
4
|
|
Open-Label Phase
Lost to Follow-up
|
4
|
2
|
|
Open-Label Phase
Physician Decision
|
1
|
0
|
|
Open-Label Phase
Protocol Violation
|
1
|
0
|
|
Open-Label Phase
Withdrawal by Subject
|
13
|
11
|
|
Open-Label Phase
Noncompliance with Study Protocol
|
4
|
2
|
|
Open-Label Phase
Failure to Exam Primary Evaluation
|
0
|
1
|
Baseline Characteristics
Gel-One Treatment in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Gel-One
n=402 Participants
The participants received a single intra-articular injection of Gel-One.
|
Placebo
n=407 Participants
The participants received a single intra-articular injection of PBS.
|
Total
n=809 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
367 Participants
n=5 Participants
|
379 Participants
n=7 Participants
|
746 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
93 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
247 Participants
n=5 Participants
|
277 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Body mass index
|
28.597 kilograms / meter square
STANDARD_DEVIATION 4.1923 • n=5 Participants
|
28.797 kilograms / meter square
STANDARD_DEVIATION 3.9244 • n=7 Participants
|
28.698 kilograms / meter square
STANDARD_DEVIATION 4.0585 • n=5 Participants
|
|
Kellgren-Lawrence score
1
|
113 participants
n=5 Participants
|
111 participants
n=7 Participants
|
224 participants
n=5 Participants
|
|
Kellgren-Lawrence score
2
|
161 participants
n=5 Participants
|
164 participants
n=7 Participants
|
325 participants
n=5 Participants
|
|
Kellgren-Lawrence score
3
|
128 participants
n=5 Participants
|
132 participants
n=7 Participants
|
260 participants
n=5 Participants
|
|
osteoarthritis knee disease duration
|
6.80 years
STANDARD_DEVIATION 7.835 • n=5 Participants
|
6.90 years
STANDARD_DEVIATION 7.072 • n=7 Participants
|
6.85 years
STANDARD_DEVIATION 7.456 • n=5 Participants
|
|
Etiology
Idiopathic
|
359 participants
n=5 Participants
|
359 participants
n=7 Participants
|
718 participants
n=5 Participants
|
|
Etiology
Post-traumatic
|
43 participants
n=5 Participants
|
48 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Study knee
Right
|
209 participants
n=5 Participants
|
212 participants
n=7 Participants
|
421 participants
n=5 Participants
|
|
Study knee
Left
|
193 participants
n=5 Participants
|
195 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
50-foot walk test VAS pain score
|
69.25 mm
STANDARD_DEVIATION 7.640 • n=5 Participants
|
69.36 mm
STANDARD_DEVIATION 7.817 • n=7 Participants
|
69.31 mm
STANDARD_DEVIATION 7.725 • n=5 Participants
|
|
50-foot walk test contralateral VAS pain score
|
11.50 mm
STANDARD_DEVIATION 7.536 • n=5 Participants
|
11.95 mm
STANDARD_DEVIATION 7.565 • n=7 Participants
|
11.73 mm
STANDARD_DEVIATION 7.549 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week26Observed 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.
Outcome measures
| Measure |
Gel-One
n=402 Participants
The participants received a single intra-articular injection of Gel-One.
|
Placebo
n=407 Participants
The participants received a single intra-articular injection of PBS.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
|
-31.7 mm
Interval -33.7 to -29.6
|
-31.7 mm
Interval -33.7 to -29.6
|
POST_HOC outcome
Timeframe: Baseline and Week 26Population: The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed.
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.
Outcome measures
| Measure |
Gel-One
n=402 Participants
The participants received a single intra-articular injection of Gel-One.
|
Placebo
The participants received a single intra-articular injection of PBS.
|
|---|---|---|
|
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26
|
-29.5 mm
Interval -32.1 to -26.9
|
—
|
Adverse Events
Gel-One
Serious events: 7 serious events
Other events: 107 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gel-One
n=404 participants at risk
3 mL, a single intra-articular injection of Gel-One.
|
Placebo
n=410 participants at risk
3 mL, a single intra-articular injection of PBS.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.25%
1/404 • 25 months
|
0.24%
1/410 • 25 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.25%
1/404 • 25 months
|
0.00%
0/410 • 25 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.25%
1/404 • 25 months
|
0.00%
0/410 • 25 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.25%
1/404 • 25 months
|
0.00%
0/410 • 25 months
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/404 • 25 months
|
0.00%
0/410 • 25 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/404 • 25 months
|
0.24%
1/410 • 25 months
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/404 • 25 months
|
0.24%
1/410 • 25 months
|
|
Infections and infestations
Osteomyelitis
|
0.25%
1/404 • 25 months
|
0.00%
0/410 • 25 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/404 • 25 months
|
0.00%
0/410 • 25 months
|
|
General disorders
Chest pain
|
0.00%
0/404 • 25 months
|
0.24%
1/410 • 25 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/404 • 25 months
|
0.24%
1/410 • 25 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/404 • 25 months
|
0.24%
1/410 • 25 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/404 • 25 months
|
0.24%
1/410 • 25 months
|
Other adverse events
| Measure |
Gel-One
n=404 participants at risk
3 mL, a single intra-articular injection of Gel-One.
|
Placebo
n=410 participants at risk
3 mL, a single intra-articular injection of PBS.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
44/404 • 25 months
|
10.2%
42/410 • 25 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
8.2%
33/404 • 25 months
|
10.2%
42/410 • 25 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
7.4%
30/404 • 25 months
|
7.1%
29/410 • 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER