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This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.
This study is a prospective, multi center randomized double blind, two arm study.
90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Conditioned Plasma (ACP) | Experimental | 3 Intra-articular (IA) injections at 1 week intervals |
|
| Normal Saline (NS) | Placebo Comparator | 3 NS Intra-articular (IA) injections at 1 week intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP | Device | Autologous Conditioned Plasma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey | The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain. | 6 month visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Smith, MD | Columbias Orthopedic Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| MedSport University of Michigan Sports Medicine |
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A total of 36 patients were excluded before randomization to groups due to not meeting Inclusion/Exclusion criteria.
A total of 126 patients were evaluated and 90 were treated at four sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Conditioned Plasma (ACP) | 3 Intra-articular (IA) injections at 1 week intervals ACP: Autologous Conditioned Plasma |
| FG001 | Normal Saline (NS) | 3 NS Intra-articular (IA) injections at 1 week intervals Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Autologous Conditioned Plasma (ACP) | Three Intra-articular injections of ACP in knee at 1 week intervals |
| BG001 | Control: Normal Saline (NS) | Three Intra-articular injections of NS in knee knee at 1 week intervals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey | The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain. | Posted | Mean | Full Range | units on a scale | 6 month visit |
|
1 year
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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 | Autologous Conditioned Plasma (ACP) | 3 Intra-articular (IA) injections at 1 week intervals ACP: Autologous Conditioned Plasma |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | Arthrex | 2395984302 | INC_ClinicalResearch@arthrex.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 16, 2017 | Jul 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo |
| Other |
Three Normal Saline IA injections of 3-8 mL at 1-week intervals. |
|
|
| Ann Arbor |
| Michigan |
| 48106 |
| United States |
| Columbia Orthopedic Group | Columbia | Missouri | 65201 | United States |
| Hawkins Foundation | Greenville | South Carolina | 29615 | United States |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| WOMAC pain score of at least 8 | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 32 |
| 60 |
| EG001 | Normal Saline (NS) | 3 NS Intra-articular (IA) injections at 1 week intervals Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals. | 0 | 30 | 0 | 30 | 21 | 30 |
| Ear Pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| eye disorder | Eye disorders | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Virus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flu | General disorders | Non-systematic Assessment |
|
| Pain in Target knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain (not in target knee) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | swelling in knee |
|
| Stiffness in target knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Atrophy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint noises in target knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Decreased range of motion in target knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Parasthesia | Nervous system disorders | Non-systematic Assessment | not device procedure or disease related |
|
| Paralysis | Nervous system disorders | Non-systematic Assessment | not device , procedure or disease related |
|
| Renal calculi | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary pain | Renal and urinary disorders | Non-systematic Assessment |
|
| cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Injection site pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | not related to device, procedure or disease |
|
| Skin CA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hematoma in target knee | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
In the Clinical Trial Agreement between sponsor and PI it states, "Institution and clinical Investigator may not publish or publicly present the results of the study without the prior written approval of sponsor."