Trial Outcomes & Findings for Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia (NCT NCT01771952)

Results Overview

Participants will be asked to rate their worst knee pain on a visual analog scale during a deep single leg squat. The scale ranges from 0-10 where higher numbers indicate more pain. A score of 0 indicates no pain and a score of 10 indicates worst possible pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

Baseline, 1 month, 3 month and 6 month

Results posted on

2020-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Synvisc-One™ Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study.	Sham Treatment Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection. Sham Treatment: A single needle stick without arthrocentesis or injection.
Overall Study STARTED	45	41
Overall Study COMPLETED	42	38
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Evaluation of the Efficacy of Synvisc-One® for the Treatment of Patellofemoral Chondromalacia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synvisc-One™ n=45 Participants Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study.	Sham Treatment n=41 Participants Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection. Sham Treatment: A single needle stick without arthrocentesis or injection.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26 years STANDARD_DEVIATION 7 • n=5 Participants	28.1 years STANDARD_DEVIATION 8.4 • n=7 Participants	27.7 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	41 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 month and 6 month

Population: 107 patients were screened, 86 were randomized (45 Synvisc one injection, 41 sham), 6 were lost to follow up leaving 42 in the Synvisc one and 38 in the sham group that completed the follow up visit and were analyzed.

Participants will be asked to rate their worst knee pain on a visual analog scale during a deep single leg squat. The scale ranges from 0-10 where higher numbers indicate more pain. A score of 0 indicates no pain and a score of 10 indicates worst possible pain.

Outcome measures

Outcome measures
Measure	Synvisc-One™ n=45 Participants Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study.	Sham Treatment n=41 Participants Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection. Sham Treatment: A single needle stick without arthrocentesis or injection.
Knee Pain During a Single Leg Squat Baseline	5.6 units on a scale Standard Deviation 1.9	5.2 units on a scale Standard Deviation 1.7
Knee Pain During a Single Leg Squat 1 month	4.1 units on a scale Standard Deviation 2.5	3.4 units on a scale Standard Deviation 2.3
Knee Pain During a Single Leg Squat 3 month	3.6 units on a scale Standard Deviation 2.5	2.2 units on a scale Standard Deviation 2.1
Knee Pain During a Single Leg Squat 6 month	2.9 units on a scale Standard Deviation 2.4	2.3 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 month and 6 month

Population: 107 patients were screened, 86 were randomized (45 Synvisc one injection, 41 sham), 6 were lost to follow up leaving 42 in the Synvisc one and 38 in the sham group that completed the follow up visit and were analyzed.

Patients will be asked to complete several validated questionnaires to assess their knee symptoms and daily function. The Knee Osteoarthritis Outcome Score (KOOS) was used as a cumulative score that included all sub-scales. The resultant score ranged from 0-100 where higher scores indicated better function.

Outcome measures

Outcome measures
Measure	Synvisc-One™ n=45 Participants Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study.	Sham Treatment n=41 Participants Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection. Sham Treatment: A single needle stick without arthrocentesis or injection.
KOOS: Patient Reported Knee Function Baseline	63.5 score on a scale Standard Deviation 11.5	64.9 score on a scale Standard Deviation 15.5
KOOS: Patient Reported Knee Function 1 month	68.9 score on a scale Standard Deviation 14.8	79.9 score on a scale Standard Deviation 11.2
KOOS: Patient Reported Knee Function 3 month	70.7 score on a scale Standard Deviation 16.6	79.9 score on a scale Standard Deviation 14.9
KOOS: Patient Reported Knee Function 6 month	74.5 score on a scale Standard Deviation 15.2	82.5 score on a scale Standard Deviation 11.5

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 month and 6 month

Population: The data reported below are from 45 patients randomized to Synvisc one and 41 patients randomized to sham.

Participants will contract their thigh muscle as hard as possible in order to measure their maximum strength. The outcome measure is maximum strength expressed in Newton-meters/kilogram. This outcome ranges from 0 indicating no strength to infinity where higher scores indicate stronger muscles.

Outcome measures

Outcome measures
Measure	Synvisc-One™ n=45 Participants Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study.	Sham Treatment n=41 Participants Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection. Sham Treatment: A single needle stick without arthrocentesis or injection.
Quadriceps Muscle Function Baseline	1.63 Newton-meters/kilogram Standard Deviation .88	1.84 Newton-meters/kilogram Standard Deviation .82
Quadriceps Muscle Function 1 month	1.77 Newton-meters/kilogram Standard Deviation .8	1.84 Newton-meters/kilogram Standard Deviation .71
Quadriceps Muscle Function 3 month	1.45 Newton-meters/kilogram Standard Deviation .82	1.68 Newton-meters/kilogram Standard Deviation .63
Quadriceps Muscle Function 6 month	1.55 Newton-meters/kilogram Standard Deviation .74	1.59 Newton-meters/kilogram Standard Deviation .7

Adverse Events

Synvisc-One™

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Synvisc-One™ n=45 participants at risk Patients randomized into this group will receive a single 6cc dose of Synvisc-One™ under sterile conditions. After cutaneous numbing with vasocoolant spray, the superolateral aspect of the patellofemoral joint will be draped and prepared with betadine soaked sterile gauze using concentric circles around the injection site. A 22 gauge needle will be advanced into the patellofemoral joint using a superolateral approach. Subjects will be monitored for minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One™: A single 6cc injection of Synvisc-One™ will be utilized in this study.	Sham Treatment n=41 participants at risk Patients randomized into this group will receive, under sterile conditions, a sham injection. Sterile preparation and injection procedures will be exactly the same as described above except, nothing will be injected into the joint. This procedure will include a needle stick through the joint without arthrocentesis or injection. Sham Treatment: A single needle stick without arthrocentesis or injection.
Musculoskeletal and connective tissue disorders Knee pain and/or stiffness	13.3% 6/45 • Number of events 6	9.8% 4/41 • Number of events 4
Musculoskeletal and connective tissue disorders Knee Effusion with or without pain	6.7% 3/45 • Number of events 3	4.9% 2/41 • Number of events 2

Additional Information

Joe Hart

University of Virginia, Kinesiology

Phone: 4349246187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place