Trial Outcomes & Findings for Synvisc-One for Younger, Active Patients With Osteoarthritis (NCT NCT01625013)

Results Overview

Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well. Minimum Clinical Important Improvement (MCII) is improvement at any time in the 26 week time frame that "Worst Knee Pain" is reported at 2 points less than baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

26 weeks after injection at baseline

Results posted on

2021-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Synvisc-One Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
Overall Study STARTED	51
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Synvisc-One for Younger, Active Patients With Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synvisc-One n=51 Participants Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
Age, Continuous	42.2 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks after injection at baseline

Population: Patients at 26 weeks post-injection Number 1

Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well. Minimum Clinical Important Improvement (MCII) is improvement at any time in the 26 week time frame that "Worst Knee Pain" is reported at 2 points less than baseline.

Outcome measures

Outcome measures
Measure	Synvisc-One n=43 Participants Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
"Worst Knee Pain" Likert Scale (0-10) Reported on Survey Patient Acceptable Symptom State (PASS)	25 Participants
"Worst Knee Pain" Likert Scale (0-10) Reported on Survey Minimum Clinical Important Improvement (MCII)	35 Participants

SECONDARY outcome

Timeframe: 26 weeks post-injection Number 2, an average of 52 weeks

Population: Patients receiving Synvisc One injection Number 2

Though symptoms can be improved for periods up to 6 months, pain symptoms can recur. The effect of repeated treatments of hylan G-F 20 will be studied with the Patient Acceptable Symptom Score less than 4/10 for the reported Worst Knee Pain score on follow up surveys. Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patient Acceptable Symptom State (PASS) is a "Worst Knee Pain" reported score of less than 4 to be "positive". Patient Acceptable Symptom State (PASS) is the highest level of symptom beyond which patients consider themselves well.

Outcome measures

Outcome measures
Measure	Synvisc-One n=37 Participants Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
Patient Acceptable Symptom Score (The Effect of Repeated Treatments) Patient Acceptable Symptom State < 4/10 worst knee pain	0 Participants
Patient Acceptable Symptom Score (The Effect of Repeated Treatments) Patient Acceptable Symptom State > 4/10	18 Participants
Patient Acceptable Symptom Score (The Effect of Repeated Treatments) Missing Data	19 Participants

SECONDARY outcome

Timeframe: up to 15 months (within 3 months from the second Synvisc One injection)

Population: Patients receiving Synvisc One injection Number 2

Though symptoms can be improved for periods up to 6 months, pain symptoms can recur. The effect of repeated treatments of hylan G-F 20 will be studied with the Minimal Clinical Important Improvement less than 2 points from baseline on a 10-point likert scale for the reported Worst Knee Pain score on any follow up survey within 3 months. Worst Knee Pain Scores were measured using a "Worst Knee Pain" Likert scale, the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. Patients can reinject after 4 months.

Outcome measures

Outcome measures
Measure	Synvisc-One n=37 Participants Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
Minimal Clinical Important Improvement (The Effect of Repeated Injections) Minimal Clinical Important Improvement more than 2 points improvement from baseline	10 Participants
Minimal Clinical Important Improvement (The Effect of Repeated Injections) MCII less than 2 points improvement from baseline	12 Participants
Minimal Clinical Important Improvement (The Effect of Repeated Injections) Missing Data	15 Participants

SECONDARY outcome

Timeframe: 26 weeks post-injection at baseline through 3 years post-injection

Population: The minimal data collected are invalid due to end user error and inaccurate data collection practices, therefore no valid data exist to report.

To identify the effects of treatment with hylan G-F 20 on activity levels (using objective activity measures utilizing accelerometer and Physical Activity Enjoyment Scale (PACES) and quality of life scores (WOMAC, SF-12) comparing baseline to treatment at 3 months.

Outcome measures

Outcome data not reported

Adverse Events

Synvisc-One

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Synvisc-One n=51 participants at risk Synvisc-One (G-F 20): Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
Musculoskeletal and connective tissue disorders Severe Swelling, Pain, and/or Stiffness	52.9% 27/51 • Adverse event data was collected at 6, 12, and 18 weeks after each injection/clinic visit, up to 3 years for each participant.
Musculoskeletal and connective tissue disorders Reinjury	3.9% 2/51 • Adverse event data was collected at 6, 12, and 18 weeks after each injection/clinic visit, up to 3 years for each participant.

Additional Information

Anthony Luke, MD

University of California, San Francisco

Phone: 4155146120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place