Osteoarthritis, Shoulder
Conditions
Keywords
Sodium Hyaluronate, Triamcinolone Hexacetonide
Brief summary
This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the shoulder joint.
Detailed description
Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). Participants to be followed to 6 Months post-injection.
Interventions
DEVICECingal
Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH).
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Screening Inclusion Criteria 1. Age 18 years or older 2. Body Mass Index (BMI) ≤ 35 kg/m2 3. Diagnosis of symptomatic osteoarthritic joint in the index shoulder (Kellgren-Lawrence grade I to III or Guyette grade I to III) to be treated with CINGAL injection. 4. Failed conservative treatment for joint osteoarthritis. 5. NRS pain ≥4 and ≤9 in the index shoulder. 6. Subject must be willing to abstain from other treatments of the index shoulder for the duration of the study. 7. Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study. 8. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up assessment, the subject is willing to discontinue use of acetaminophen/paracetamol. 9. Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing the informed consent form (ICF). 10. Able and willing to provide signed informed consent. Baseline Inclusion Criteria 1\. NRS pain ≥4 and ≤9 in index shoulder Screening
Exclusion criteria
1. History of hypersensitivity to any of the ingredients in the hyaluronan or corticosteroids 2. Infection or skin disease in the area of the injection site or index shoulder 3. NRS pain \> 3 in the contralateral shoulder 4. Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study. 5. Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index shoulder or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements. 6. Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study. 7. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index shoulder only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed. 8. Significant trauma to the index shoulder within 26 weeks of screening. 9. Chronic use of narcotics or cannabis. Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain | 6 months | Reduction of Index Shoulder Numerical Rating Scale (NRS) Pain from baseline to 6 months post injection was obtained from participant responses. The NRS Pain Score is an 11-point Likert scale ranged from 0 = No Pain to 10 = Worst Pain level. A negative value for the change in NRS Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) Score | 6 Months | Improvement in pain and function in the index shoulder from baseline to 6 months as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores for each question range from 0 (no pain or disability) to 100 (most severe pain or disability) and are averaged to calculate the final DASH score from 0 to 100. A negative value for the change in DASH score indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome. |
| Patient Global Assessment (PGA) Score | 6 Months | The change from baseline to 6 months in index shoulder pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) shoulder is bothering them today . The PGA Score is a validated 11-point Likert scale from 0 = No Pain to 10 = Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value indicates less pain, and a better clinical outcome. |
| The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment | 6 Months | The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of participants that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome |
| Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication. | 6 Months | The usage of Rescue Medication (RM) as based on the number of participants at 6 Months post treatmentthat were NOT using acetominophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain. |
Countries
Czechia, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cingal Single injection into the hip joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Cingal |
|---|---|
| Age, Continuous | 60.12 years STANDARD_DEVIATION 9.52 |
| Index Shoulder Left | 8 Participants |
| Index Shoulder Right | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 5 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Numerical Rating Scale (NRS) Pain
Reduction of Index Shoulder Numerical Rating Scale (NRS) Pain from baseline to 6 months post injection was obtained from participant responses. The NRS Pain Score is an 11-point Likert scale ranged from 0 = No Pain to 10 = Worst Pain level. A negative value for the change in NRS Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome.
Time frame: 6 months
Population: Intent To Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cingal | Numerical Rating Scale (NRS) Pain | -3.72 score on a scale | Standard Deviation 2.19 |
p-value: <0.0001ANOVA
Secondary
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Improvement in pain and function in the index shoulder from baseline to 6 months as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores for each question range from 0 (no pain or disability) to 100 (most severe pain or disability) and are averaged to calculate the final DASH score from 0 to 100. A negative value for the change in DASH score indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome.
Time frame: 6 Months
Population: Intent To Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cingal | Disabilities of the Arm, Shoulder and Hand (DASH) Score | -38.40 score on a scale | Standard Deviation 14.89 |
p-value: <0.0001ANOVA
Secondary
Patient Global Assessment (PGA) Score
The change from baseline to 6 months in index shoulder pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) shoulder is bothering them today . The PGA Score is a validated 11-point Likert scale from 0 = No Pain to 10 = Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value indicates less pain, and a better clinical outcome.
Time frame: 6 Months
Population: Intent To Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cingal | Patient Global Assessment (PGA) Score | -3.88 score on a scale | Standard Deviation 2.35 |
p-value: <0.0001ANOVA
Secondary
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment
The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of participants that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome
Time frame: 6 Months
Population: Intent To Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cingal | The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment | 24 Participants |
Secondary
Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.
The usage of Rescue Medication (RM) as based on the number of participants at 6 Months post treatmentthat were NOT using acetominophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.
Time frame: 6 Months
Population: Intent To Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cingal | Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication. | 21 Participants |