Osteoarthritis of the Hip
Conditions
Brief summary
This study is being done to determine the effectiveness of MONOVISC for the relief of pain and symptoms of osteoarthritis of the hip. Specifically, the study will determine if MONOVISC is more effective than a placebo treatment when delivered as intra-articular injections (injected directly into the hip joint). In this case, the placebo will be a dilute solution of salt water (saline).
Detailed description
The primary objective of this study is determine whether two intra-articular injections of MONOVISC, separated by 1 month, are superior to two intra-articular injections of physiologic saline, separated by 1 month, in relieving hip osteoarthritis pain, as determined by reduction in walking pain change from baseline.
Interventions
DEVICEMONOVISC
Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
DEVICESaline
Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
Sponsors
DePuy Mitek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 30 years old * Body Mass Index (BMI) ≤ 35 * Clinical or radiographic diagnosis of hip osteoarthritis in the target hip, with a Kellgren-Lawrence (K/L) grade of 2 or 3. * Walking pain NRS ≥ 4 and ≤ 8. * Willing to discontinue all pain medications (except rescue medication) for 7 days prior to the first study injection and for the duration of the study. * Willing to discontinue rescue medication for 48 hours prior to the first study injection. * Willing to discontinue rescue medication for 48 hours prior to all follow-up visits * Ability to tolerate acetaminophen (e.g. Tylenol). * Must be physically and mentally willing and able to comply with pre and post-treatment scheduled clinical and radiographic evaluations * Must voluntarily sign the Institutional Review Board approved Informed Consent Form. * Must agree not to initiate cannabis therapy during the trial study period.
Exclusion criteria
* Radiographic evidence of osteonecrosis in the target hip * NRS walking pain ≥ 3 the contralateral hip * Clinically diagnosed osteoarthritis in either knee resulting in walking pain greater than NRS 5. * Dependence on external stabilization for walking (e.g. cane, crutches, walker, etc.) * Pain associated with lower back disorders that cannot be differentiated from target hip pain * Major dysplasia or congenital abnormality * Diagnosis of fibromyalgia * Primary inflammatory arthropathy, or any other condition affecting the joint, including rheumatoid arthritis or gout in the target hip * Any musculoskeletal condition that could impede efficacy measurement of the target hip * Any major surgery, arthroplasty, or arthroscopy of the lower extremities in the past 6 months, or planned surgery during the study * Infection of the injection site area * Chronic skin disorders that could interfere with injection site evaluation * Patients with asthma who require systemic use of corticosteroids * Septic arthritis in any joint in the past 12 weeks * For all patients: known hypersensitivity to hyaluronan, lidocaine, or acetaminophen * For patients undergoing fluoroscopic injection guidance: known hypersensitivity to iodine-based fluoroscopic contrast agents, shellfish, or iodine * Intra-articular steroid injection of the target hip within the last 3 months or hyaluronan injection of the target hip within the last 26 weeks * Systemic corticosteroids within the last 12 weeks * Glucosamine and/or chondroitin sulfate within last 4 weeks * Currently on anticoagulation therapy, including aspirin therapy of \> 81 mg/day (e.g. one daily baby aspirin). * Uncontrolled diabetes mellitus. * Pregnant or breast feeding, or plan to be pregnant during the course of the study * Any significant illness (metastasis of any type) that decreases the probability of the subject's survival to the 26 week endpoint * Patients unwilling/unable to complete a pain/function and quality of life questionnaires * Significant trauma to the index hip within 26 weeks of screening * Is receiving workman's compensation, or is currently involved in litigation relating to hip osteoarthritis * Is receiving prescription pain medication for conditions unrelated to hip osteoarthritis * Chronic use of narcotics * Unwilling to return for follow-up visits as described in this protocol * Otherwise determined by the investigator to be medically unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180 | Baseline and Day 180 | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Baseline, Day 14, 28, 60 and 120 | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Monovisc Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31. | 140 |
| Saline Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31. | 80 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Other | 11 | 11 |
| Overall Study | Physician Decision | 0 | 4 |
| Overall Study | Withdrawal by Subject | 20 | 16 |
Baseline characteristics
| Characteristic | Saline | Total | Monovisc |
|---|---|---|---|
| Age, Continuous | 59.4 Years STANDARD_DEVIATION 10.8 | 58.8 Years STANDARD_DEVIATION 10.01 | 58.5 Years STANDARD_DEVIATION 9.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 30 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 190 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 75 Participants | 208 Participants | 133 Participants |
| Sex: Female, Male Female | 46 Participants | 130 Participants | 84 Participants |
| Sex: Female, Male Male | 34 Participants | 90 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 80 |
| other Total, other adverse events | 25 / 140 | 12 / 80 |
| serious Total, serious adverse events | 2 / 140 | 0 / 80 |
Outcome results
Primary
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain.
Time frame: Baseline and Day 180
Population: Safety Analysis Set (SAS) consists of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure (OM).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monovisc | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180 | -1.75 Units on a scale | Standard Deviation 2.88 |
| Saline | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180 | -1.53 Units on a scale | Standard Deviation 3.21 |
Secondary
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain.
Time frame: Baseline, Day 14, 28, 60 and 120
Population: SAS consists of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received. Here 'n'(number analyzed) signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monovisc | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 14 | -1.44 Units on a scale | Standard Deviation 2.32 |
| Monovisc | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 28 | -1.42 Units on a scale | Standard Deviation 2.46 |
| Monovisc | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 60 | -1.89 Units on a scale | Standard Deviation 2.76 |
| Monovisc | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 120 | -1.97 Units on a scale | Standard Deviation 2.79 |
| Saline | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 120 | -1.58 Units on a scale | Standard Deviation 2.8 |
| Saline | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 14 | -1.16 Units on a scale | Standard Deviation 2.14 |
| Saline | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 60 | -1.75 Units on a scale | Standard Deviation 2.31 |
| Saline | Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 | Change at Day 28 | -1.13 Units on a scale | Standard Deviation 2.19 |