Trial Outcomes & Findings for Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis (NCT NCT01753830)

Last Updated: 2022-08-26

Results Overview

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.

Recruitment status

TERMINATED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

Up to 30 weeks

Results posted on

2022-08-26

Participant milestones
Measure	Durolane Single intraarticular injection of Durolane Durolane	Phosphate Buffered Saline (PBS) Single intraarticular injection of PBS PBS
Overall Study STARTED	37	38
Overall Study COMPLETED	30	35
Overall Study NOT COMPLETED	7	3

Withdrawal data not reported

Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Baseline characteristics by cohort
Measure	Durolane n=37 Participants Single intraarticular injection of Durolane Durolane	Phosphate Buffered Saline (PBS) n=38 Participants Single intraarticular injection of PBS PBS	Total n=75 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 8.89 • n=5 Participants	59.6 years STANDARD_DEVIATION 8.94 • n=7 Participants	58.7 years STANDARD_DEVIATION 8.90 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	33 Participants n=7 Participants	64 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
Region of Enrollment United States	37 participants n=5 Participants	38 participants n=7 Participants	75 participants n=5 Participants

Timeframe: Up to 30 weeks

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.

Outcome measures
Measure	Durolane n=37 Participants Single intraarticular injection of Durolane Durolane	Phosphate Buffered Saline (PBS) n=38 Participants Single intraarticular injection of PBS PBS
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30	-32.3 units on a scale Standard Deviation 19.64	-26.8 units on a scale Standard Deviation 20.17

Serious events: 2 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events
Measure	Durolane n=37 participants at risk Single intraarticular injection of Durolane Durolane	Phosphate Buffered Saline (PBS) n=38 participants at risk Single intraarticular injection of PBS PBS
Cardiac disorders Cardiac arrest	2.7% 1/37 • Number of events 1	0.00% 0/38
Cardiac disorders Cardiac failure congestive	2.7% 1/37 • Number of events 1	0.00% 0/38
Gastrointestinal disorders Abdominal pain lower	0.00% 0/37	2.6% 1/38 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.7% 1/37 • Number of events 1	0.00% 0/38
Infections and infestations Pneumonia	0.00% 0/37	2.6% 1/38 • Number of events 1

Other adverse events
Measure	Durolane n=37 participants at risk Single intraarticular injection of Durolane Durolane	Phosphate Buffered Saline (PBS) n=38 participants at risk Single intraarticular injection of PBS PBS
General disorders Injection site joint pain	5.4% 2/37 • Number of events 2	0.00% 0/38
General disorders Injection site pain	8.1% 3/37 • Number of events 3	5.3% 2/38 • Number of events 2
General disorders Injection site erythema	0.00% 0/37	5.3% 2/38 • Number of events 2
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/37	5.3% 2/38 • Number of events 2
Musculoskeletal and connective tissue disorders Back pain	5.4% 2/37 • Number of events 2	7.9% 3/38 • Number of events 3
Musculoskeletal and connective tissue disorders Joint effusion	5.4% 2/37 • Number of events 2	7.9% 3/38 • Number of events 3
Musculoskeletal and connective tissue disorders Joint stiffness	5.4% 2/37 • Number of events 2	7.9% 3/38 • Number of events 3
Musculoskeletal and connective tissue disorders Joint swelling	18.9% 7/37 • Number of events 7	7.9% 3/38 • Number of events 3
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 1/37 • Number of events 1	5.3% 2/38 • Number of events 2
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/37	7.9% 3/38 • Number of events 4

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