Trial Outcomes & Findings for Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis (NCT NCT01557868)

Last Updated: 2014-04-02

Results Overview

The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the "best" score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

198 participants

Primary outcome timeframe

Baseline and at 6 month follow-up

Results posted on

2014-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Synvisc (Hylan G-F 20) hylan G-F 20: Three 2 cc injections at weekly intervals	Euflexxa (1% Sodium Hyaluronate) 1% sodium hyaluronate: Three 2 cc injections at weekly intervals
Overall Study STARTED	103	95
Overall Study COMPLETED	76	65
Overall Study NOT COMPLETED	27	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synvisc (Hylan G-F 20) n=103 Participants hylan G-F 20: Three 2 cc injections at weekly intervals	Euflexxa (1% Sodium Hyaluronate) n=95 Participants 1% sodium hyaluronate: Three 2 cc injections at weekly intervals	Total n=198 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 9.6 • n=5 Participants	43.3 years STANDARD_DEVIATION 10.4 • n=7 Participants	45.0 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	35 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	33 participants n=5 Participants	21 participants n=7 Participants	54 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized White	62 participants n=5 Participants	62 participants n=7 Participants	124 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants	95 participants n=7 Participants	198 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at 6 month follow-up

Outcome measures

Outcome measures
Measure	Synvisc (Hylan G-F 20) n=76 Participants hylan G-F 20: Three 2 cc injections at weekly intervals	Euflexxa (1% Sodium Hyaluronate) n=65 Participants 1% sodium hyaluronate: Three 2 cc injections at weekly intervals
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale	12.8 units on a scale Standard Deviation 18.9	9.8 units on a scale Standard Deviation 20.5

SECONDARY outcome

Timeframe: Assessments were at baseline to 6 month follow-up

Population: The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable.

The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement.

Outcome measures

Outcome measures
Measure	Synvisc (Hylan G-F 20) n=76 Participants hylan G-F 20: Three 2 cc injections at weekly intervals	Euflexxa (1% Sodium Hyaluronate) n=64 Participants 1% sodium hyaluronate: Three 2 cc injections at weekly intervals
Visual Analogue Scale (VAS) at 6 Months	-13.7 units on a scale Standard Deviation 28.4	-10.7 units on a scale Standard Deviation 25.4

Adverse Events

Synvisc (Hylan G-F 20)

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Euflexxa (1% Sodium Hyaluronate)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Synvisc (Hylan G-F 20) n=103 participants at risk hylan G-F 20: Three 2 cc injections at weekly intervals	Euflexxa (1% Sodium Hyaluronate) n=95 participants at risk 1% sodium hyaluronate: Three 2 cc injections at weekly intervals
Musculoskeletal and connective tissue disorders Knee Effusion	7.8% 8/103 • Number of events 8 • 1 year	1.1% 1/95 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barton Mann

American Orthopaedic Society for Sports Medicine

Phone: 847-292-4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place