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| Name | Class |
|---|---|
| Integra LifeSciences Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioDRestore™ | Experimental | BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint. |
|
| Corticosteroid | Active Comparator | Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioD Restore | Device | Investigational product, BioD Restore, will be injected into the articular space of the knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Surgery through 12 months post-op/ |
| 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 | Sugery to 12 months post-op |
| Lysholm Knee Score | Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms. | Surgery to 12 months post-op. |
| 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. | Surgery to 12 months post-op. |
| 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. | Surgery to 12 months post op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Siffri, MD | Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas | Greenville | South Carolina | 29615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39813395 | Derived | Pill SG, Ahearn B, Tokish JM, Cook C, Siffri PJ, Mercuri JJ, Burnikel B, Cassas KJ, Wyland DJ, Sawvell E, Wright N, Hutchinson J, Bynarowicz T, Adams KJ, Kissenberth MJ. Amniotic Tissue Injections Are an Effective Alternative to Corticosteroid Injections for Pain Relief and Function in Patients With Severe Knee Osteoarthritis: A Double-Blind, Randomized, Prospective Study. J Am Acad Orthop Surg Glob Res Rev. 2025 Jan 9;9(1):e23.00276. doi: 10.5435/JAAOSGlobal-D-23-00276. eCollection 2025 Jan 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Corticosteroid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Surgery through 12 months post-op/ |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Adams | Hawkins Foundation | 864 454-7458 | kyle.adams@hawkinsfoundation.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2017 | Oct 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Kenalog | Drug | Active comparator, Kenalog steroid, will be injected into the articular space of the knee. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Sugery to 12 months post-op |
|
|
|
| Primary | Lysholm Knee Score | Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms. | Posted | Mean | Standard Deviation | score on a scale | Surgery to 12 months post-op. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Surgery to 12 months post-op. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Surgery to 12 months post op |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 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. | 0 | 45 | 0 | 45 | 0 | 45 |
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| D012216 |
| Rheumatic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |