Trial Outcomes & Findings for ORTHOVISC Shoulder Osteoarthritis Study (NCT NCT00436969)

NCT ID: NCT00436969

Last Updated: 2017-03-09

Results Overview

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 274 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2017-03-09

Participant Flow

Enrollment occurred between January 2007 and February 2010 at 13 sites based in the US.

Four subjects were randomized; however due to required imaging inclusion/exclusion criteria was not met. Hence, these 4 subjects were not treated.

Participant milestones

Measure	Control Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Overall Study STARTED	88	186
Overall Study Randomized But Not Treated	1	3
Overall Study COMPLETED	66	134
Overall Study NOT COMPLETED	22	52

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ORTHOVISC Shoulder Osteoarthritis Study

Baseline characteristics by cohort

Measure	Control n=87 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=183 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.	Total n=270 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 9.84 • n=5 Participants	58.6 years STANDARD_DEVIATION 10.68 • n=7 Participants	58.4 years STANDARD_DEVIATION 10.40 • n=5 Participants
Age, Customized 18 to 29	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Age, Customized 30 and 39 years	4 participants n=5 Participants	11 participants n=7 Participants	15 participants n=5 Participants
Age, Customized 40 to 49 years	11 participants n=5 Participants	22 participants n=7 Participants	33 participants n=5 Participants
Age, Customized 50 to 59 years	22 participants n=5 Participants	50 participants n=7 Participants	72 participants n=5 Participants
Age, Customized 60 to 69 years	43 participants n=5 Participants	68 participants n=7 Participants	111 participants n=5 Participants
Age, Customized 70 to 79 years	6 participants n=5 Participants	31 participants n=7 Participants	37 participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	44 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	139 Participants n=7 Participants	205 Participants n=5 Participants
Region of Enrollment United States	87 participants n=5 Participants	183 participants n=7 Participants	270 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

Outcome measures

Measure	Control n=58 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=107 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Visual Analog Scale (VAS) Pain Score (Per Protocol)	30.389 mm on a 100 mm VAS scale Standard Error 3.035	28.917 mm on a 100 mm VAS scale Standard Error 2.233

PRIMARY outcome

Timeframe: 6 Months

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

Outcome measures

Measure	Control n=64 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=132 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Visual Analog Scale (VAS) Pain Score (As Treated)	33.196 mm on a 100 mm VAS scale Standard Error 2.777	30.406 mm on a 100 mm VAS scale Standard Error 1.926

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.

Outcome measures

Measure	Control n=58 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=107 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)	63.8 Percentage of Participants Interval 50.1 to 76.0	63.6 Percentage of Participants Interval 53.7 to 72.6

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.

Outcome measures

Measure	Control n=67 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=136 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)	59.7 Percentage of Participants Interval 47.0 to 71.5	54.4 Percentage of Participants Interval 45.7 to 63.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).

The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.

Outcome measures

Measure	Control n=49 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=91 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)	-23.624 mm on a 100 mm VAS scale Standard Error 3.206	-24.494 mm on a 100 mm VAS scale Standard Error 2.356

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

The difference in pain was calculated as visit score - baseline score.

Outcome measures

Measure	Control n=65 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=135 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)	-16.882 mm on a 100 mm VAS scale Standard Error 2.757	-19.756 mm on a 100 mm VAS scale Standard Error 1.909

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).

The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.

The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.

Outcome measures

Measure	Control n=41 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=75 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)	18.329 units on a scale Standard Error 2.578	17.397 units on a scale Standard Error 1.917

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.

The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.

Outcome measures

Measure	Control n=56 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=104 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)	12.960 units on a scale Standard Error 2.197	13.988 units on a scale Standard Error 1.605

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.

The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.

The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.

Outcome measures

Measure	Control n=50 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=84 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)	18.228 units on a scale Standard Error 2.438	17.408 units on a scale Standard Error 1.858

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.

The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.

Outcome measures

Measure	Control n=53 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=98 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)	14.272 units on a scale Standard Error 2.237	15.402 units on a scale Standard Error 1.636

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).

The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.

Scoring instructions: The scores from both dimensions are averaged to derive a total score.

Outcome measures

Measure	Control n=48 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=87 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)	-17.871 units on a scale Standard Error 2.477	-10.554 units on a scale Standard Error 1.830

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.

Scoring instructions: The scores from both dimensions are averaged to derive a total score.

Outcome measures

Measure	Control n=68 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=129 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)	-11.828 units on a scale Standard Error 2.132	-9.467 units on a scale Standard Error 1.531

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.

The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.

Scoring instructions: The scores from both dimensions are averaged to derive a total score.

Outcome measures

Measure	Control n=55 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=102 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)	-16.109 units on a scale Standard Error 2.390	-13.492 units on a scale Standard Error 1.752

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.

Scoring instructions: The scores from both dimensions are averaged to derive a total score.

Outcome measures

Measure	Control n=63 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=127 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)	-10.314 units on a scale Standard Error 2.179	-12.522 units on a scale Standard Error 1.539

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).

The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=48 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=90 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)	3.607 units on a scale Standard Error 1.050	2.050 units on a scale Standard Error 0.771

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=67 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=133 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)	2.179 units on a scale Standard Error 0.877	1.950 units on a scale Standard Error 0.624

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.

The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=55 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=102 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)	2.763 units on a scale Standard Error 1.009	2.831 units on a scale Standard Error 0.743

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=63 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=126 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)	1.559 units on a scale Standard Error 0.896	2.779 units on a scale Standard Error 0.635

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).

The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=48 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=90 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)	-0.130 units on a scale Standard Error 0.991	1.060 units on a scale Standard Error 0.726

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=67 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=133 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)	0.167 units on a scale Standard Error 0.875	0.938 units on a scale Standard Error 0.623

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.

The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=55 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=102 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)	0.397 units on a scale Standard Error 0.941	0.379 units on a scale Standard Error 0.692

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: The As Treated analysis population included all subjects that received treatment and had outcome data.

The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.

The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.

Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Measure	Control n=63 Participants Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).	Investigational n=126 Participants Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)	0.330 units on a scale Standard Error 0.897	0.798 units on a scale Standard Error 0.636

Adverse Events

Control

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Investigational

Serious events: 10 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=87 participants at risk Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).	Investigational n=183 participants at risk Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Cardiac disorders Chest Pain - Cardiac Cath to Rule Out Cad	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.55% 1/183 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Musculoskeletal and connective tissue disorders Knee Pain Both Knees	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.55% 1/183 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Musculoskeletal and connective tissue disorders Shoulder Pain (Index Shoulder) Right Shoulder	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	1.1% 2/183 • Number of events 2 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	1.1% 1/87 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.00% 0/183 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Patient has cancer, did not specify to PI where cancer is, never returned, lost to follow-up	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.55% 1/183 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Surgical and medical procedures Total Shoulder Arthroplasty Plus Bone Graft Glenoid Scapular Right Shoulder	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	1.1% 2/183 • Number of events 2 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Musculoskeletal and connective tissue disorders Left Shoulder Pain Non-Study Shoulder - Surgery 6/10/09	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.55% 1/183 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Surgical and medical procedures Quadruple Bypass 5/6/09	1.1% 1/87 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.00% 0/183 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Infections and infestations Iliopsoas Abscess	1.1% 1/87 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.00% 0/183 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.55% 1/183 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.
Cardiac disorders Open Heart Surgery After Aortic Valve Disease	0.00% 0/87 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	0.55% 1/183 • Number of events 1 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.

Other adverse events

Measure	Control n=87 participants at risk Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).	Investigational n=183 participants at risk Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.9% 6/87 • Number of events 6 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.	10.4% 19/183 • Number of events 21 • The first subject was randomized and treated in January, 2007. The last subject completed the study in August, 2010. Total timeframe: 3 years, 7 months All subjects that received study treatment are included in the safety population.

Additional Information

Aileen Michael

DePuy Mitek

Phone: 508.828.3337

Email: amichae2@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60