Trial Outcomes & Findings for Optimization of Synvisc-One for Knee OA (NCT NCT02029703)

Results Overview

The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection. The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

12 and 24 weeks

Results posted on

2017-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Injection Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis. Sham Injection	Synvisc-One Injection Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One Injection
Overall Study STARTED	20	22
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimization of Synvisc-One for Knee OA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Injection n=20 Participants Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis. Sham Injection	Synvisc-One Injection n=22 Participants Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One Injection	Total n=42 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 13.4 • n=5 Participants	59.2 years STANDARD_DEVIATION 10.2 • n=7 Participants	60.1 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Number of Participants	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 and 24 weeks

The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection. The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score.

Outcome measures

Outcome measures
Measure	Sham Injection n=20 Participants Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.	Synvisc-One Injection n=22 Participants Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One Injection
Difference in Pain Score Between Groups Pain Subscale over 12 Weeks	69.6 units on a scale Standard Deviation 18	70.3 units on a scale Standard Deviation 20
Difference in Pain Score Between Groups Pain Subsclale over 24 Weeks	70.4 units on a scale Standard Deviation 18.7	70.5 units on a scale Standard Deviation 22.3

Adverse Events

Sham Injection

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Synvisc-One Injection

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sham Injection n=20 participants at risk Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis. Sham Injection	Synvisc-One Injection n=22 participants at risk Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One Injection
Psychiatric disorders Depression Requiring Hospitalization	0.00% 0/20 • 3 Years Depression Requiring Hospitalization	4.5% 1/22 • 3 Years Depression Requiring Hospitalization

Other adverse events

Other adverse events
Measure	Sham Injection n=20 participants at risk Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis. Sham Injection	Synvisc-One Injection n=22 participants at risk Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events. Synvisc-One Injection
Musculoskeletal and connective tissue disorders Worsening Knee Pain	15.0% 3/20 • Number of events 4 • 3 Years Depression Requiring Hospitalization	9.1% 2/22 • Number of events 2 • 3 Years Depression Requiring Hospitalization

Additional Information

M. Elaine Husni, MD, MPH

Cleveland Clinic

Phone: 216-445-1853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place