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The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis
Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.
Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronized dHACM | Experimental | Injection of micronized dHACM |
|
| Saline | Placebo Comparator | Injection of 0.9% Sodium Chloride Injection, USP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronized dHACM | Biological | Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days | Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain | 90 days |
| Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days | Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | 90 days |
| Primary Safety Endpoint: Number of Participants With Adverse Events (AEs) | Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported | 365 days |
| Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs) | Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported | 365 days |
| Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events | Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days | Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain | 180 days |
| Secondary Endpoint:Change From Baseline in WOMAC at 180 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days | VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain | Up to 365 days |
| Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 Days |
Inclusion Criteria:
Exclusion Criteria:
Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
BMI greater than 40 kg/m^2
Subject has active infection at the injection site
Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
Subject has documented history of gout or pseudo-gout
Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
Subject has received any of the following to the target knee:
Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
Subject has a history of immunosuppressive or chemotherapy in the last 5 years
Subject has had prior radiation at the site
Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
Subject is pregnant or plans to become pregnant within 365 days of treatment
Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
Subject is a worker's compensation patient
Subject is a prisoner
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| Name | Affiliation | Role |
|---|---|---|
| Alfred C Gellhorn, MD | Esprit R&D Associate GSK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, Inc | Birmingham | Alabama | 35205 | United States | ||
| Fiel Family and Sports Medicine |
Screening visit occurred after enrollment and could possibly be the same day as randomization/treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micronized dHACM | Injection of micronized dHACM Micronized dHACM: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP |
| FG001 | Saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2020 | Dec 6, 2023 |
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| Saline | Drug | Injection of 1 mL 0.9% Sodium Chloride, USP |
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| 180 days |
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| Up to 365 days |
| Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days | VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction | Up to 365 days |
| Exploratory Endpoint: Change From Baseline in the KOOS Scores at 90, 180, 270, and 365 Days | Knee Injury and Osteoarthritis Outcome Score (KOOS): 5 subscales scored on a 5 point scale where the final score is summed and transformed into a 100 point scale with a higher score representing no disability and a lower score representing extreme disability | Up to 365 days |
| Tempe |
| Arizona |
| 85283 |
| United States |
| Horizon Clinical Research | La Mesa | California | 91942 | United States |
| UConn Health | Farmington | Connecticut | 06030 | United States |
| Bone & Joint Inst. at Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Gulfcoast Research Institute | Sarasota | Florida | 34232 | United States |
| Paragon Sports Medicine | Atlanta | Georgia | 30327 | United States |
| Hinsdale Orthopedics | Hinsdale | Illinois | 60521 | United States |
| Arthritis Care Specialist of Maryland | Columbia | Maryland | 21046 | United States |
| MedSport | Ann Arbor | Michigan | 48106 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| Wake Reseach | Durham | North Carolina | 27704 | United States |
| Wake Research | Raleigh | North Carolina | 27612 | United States |
| University Orthopedics Center | Altoona | Pennsylvania | 16602 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| SAMMC | Fort Sam Houston | Texas | 78234 | United States |
| Ortho Virginia | Richmond | Virginia | 23294 | United States |
Injection of 0.9% Sodium Chloride Injection, USP
Saline: Injection of 1 mL 0.9% Sodium Chloride, USP
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open Label Phase |
|
|
Demographic and baseline characteristics of subjects in the ITT Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Micronized dHACM | Injection of micronized dHACM Micronized dHACM: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP |
| BG001 | Saline | Injection of 0.9% Sodium Chloride Injection, USP Saline: Injection of 1 mL 0.9% Sodium Chloride, USP |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| ||||||||||||||||
| Height (in) | Mean | Standard Deviation | Inches |
| |||||||||||||||
| Weight | Mean | Standard Deviation | lbs |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days | Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain | Population: Intent To Treat Set | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days | Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Population: Intent To Treat Set | Posted | Mean | Standard Deviation | score on a scale | 90 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Primary Safety Endpoint: Number of Participants With Adverse Events (AEs) | Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported | Subjects with at least 1 Treatment Emergent Adverse Event reported | Posted | Count of Participants | Participants | 365 days |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs) | Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported | Subjects reporting Serious Adverse Events | Posted | Count of Participants | Participants | 365 days |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events | Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported | Subjects reporting Unanticipated Treatment Emergent Adverse Events | Posted | Count of Participants | Participants | 365 days |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days | Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain | Population: Intent To Treat | Posted | Mean | Standard Deviation | score on a scale | 180 days |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Endpoint:Change From Baseline in WOMAC at 180 Days | Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Population: Intent To Treat | Posted | Mean | Standard Deviation | score on a scale | 180 days |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days | VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain | Not Posted | Up to 365 days | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 Days | Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Not Posted | Up to 365 days | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days | VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction | Not Posted | Up to 365 days | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Endpoint: Change From Baseline in the KOOS Scores at 90, 180, 270, and 365 Days | Knee Injury and Osteoarthritis Outcome Score (KOOS): 5 subscales scored on a 5 point scale where the final score is summed and transformed into a 100 point scale with a higher score representing no disability and a lower score representing extreme disability | Not Posted | Up to 365 days | Participants |
Adverse Events were collects for 1 year in the double blinded study and 6 months in the Open Label Study.
Not provided
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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 | Micronized dHACM | Injection of micronized dHACM Micronized dHACM: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP | 0 | 223 | 11 | 223 | 123 | 223 |
| EG001 | Saline | Injection of 0.9% Sodium Chloride Injection, USP Saline: Injection of 1 mL 0.9% Sodium Chloride, USP | 0 | 224 | 12 | 224 | 120 | 224 |
| EG002 | Open-Label Micronized dHACM | Open-label injection of micronized dHACM Micronized dHACM: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP | 0 | 217 | 5 | 217 | 94 | 217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal stromal tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Injection site joint pain | General disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint noise | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthroplasty | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Injection site joint pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site joint swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Effusion | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Iliotibial band syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Latent syphilis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral respiratory infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Restless leg syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mouth swelling | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinonasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA | Systematic Assessment |
| |
| Thyroid hormones increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Veritgo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Foot operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Knee arthoroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Rotator cuff repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Post cholecystectomy hyperplasia | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site joint movement impairment | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Immunisation reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | MIMEDX | (770) 651-9100 | CTInquiries@mimedx.com |
| Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2020 | Dec 6, 2023 | SAP_005.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Withdrawal by Subject |
|
| Removal by PI |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|