Knee Osteoarthritis
Conditions
Brief summary
This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.
Interventions
DEVICEBioD Restore
Investigational product, BioD Restore, will be injected into the articular space of the knee.
DRUGKenalog
Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
Sponsors
Integra LifeSciences Corporation
The Hawkins Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 to 80 years. * Willing and able to give voluntary informed consent to participate in this investigation. * Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray). * Candidate for intra-articular knee injection. * BMI \< 40
Exclusion criteria
* Patients who have received intra-articular injection(s) in the last 3 months. * Patients who have undergone arthroscopic surgery on the study knee in the past year. * Patients who have undergone arthroplasty on the study knee. * Ligament instability * Diabetes (Type 1 or II) * Inflammatory arthropathies. * Fibromyalgia or chronic fatigue syndrome. * Female patient who is pregnant or nursing. * Chronic use of narcotics. * Any other reason (in the judgment of the investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Score | Surgery through 12 months post-op/ | Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain. |
| Veterans Rand 12 Item Health Survey | Sugery to 12 months post-op | Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores |
| Lysholm Knee Score | Surgery to 12 months post-op. | Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms. |
| Single Alpha Numeric Evaluation (SANE) | Surgery to 12 months post-op. | Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly normal knee and 0 being a completely abnormal knee. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Surgery to 12 months post op | Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BioDRestore™ BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.
BioD Restore: Investigational product, BioD Restore, will be injected into the articular space of the knee. | 45 |
| Corticosteroid Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.
Kenalog: Active comparator, Kenalog steroid, will be injected into the articular space of the knee. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | BioDRestore™ | Corticosteroid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 16 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 29 Participants | 57 Participants |
| Age, Continuous | 61.86 years STANDARD_DEVIATION 8.98 | 64.03 years STANDARD_DEVIATION 8.92 | 62.92 years STANDARD_DEVIATION 8.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 44 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 43 Participants | 42 Participants | 85 Participants |
| Region of Enrollment United States | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 53 Participants |
| Sex: Female, Male Male | 17 Participants | 20 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems.
Time frame: Surgery to 12 months post op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioDRestore™ | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 64.10 score on a scale | Standard Deviation 21.23 |
| Corticosteroid | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 55.67 score on a scale | Standard Deviation 22.23 |
Primary
Lysholm Knee Score
Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.
Time frame: Surgery to 12 months post-op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioDRestore™ | Lysholm Knee Score | 75.26 score on a scale | Standard Deviation 17.75 |
| Corticosteroid | Lysholm Knee Score | 61.00 score on a scale | Standard Deviation 22 |
Primary
Single Alpha Numeric Evaluation (SANE)
Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly normal knee and 0 being a completely abnormal knee.
Time frame: Surgery to 12 months post-op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioDRestore™ | Single Alpha Numeric Evaluation (SANE) | 66.14 score on a scale | Standard Deviation 23.27 |
| Corticosteroid | Single Alpha Numeric Evaluation (SANE) | 60.49 score on a scale | Standard Deviation 25.37 |
Primary
Veterans Rand 12 Item Health Survey
Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores
Time frame: Sugery to 12 months post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioDRestore™ | Veterans Rand 12 Item Health Survey | 56.95 score on a scale | Standard Deviation 9.84 |
| Corticosteroid | Veterans Rand 12 Item Health Survey | 58.01 score on a scale | Standard Deviation 7.49 |
Primary
Visual Analog Pain Score
Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.
Time frame: Surgery through 12 months post-op/
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioDRestore™ | Visual Analog Pain Score | 2.49 score on a scale | Standard Deviation 2.41 |
| Corticosteroid | Visual Analog Pain Score | 3.25 score on a scale | Standard Deviation 2.82 |