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A pivotal study to assess the safety and effectiveness of the InSpaceâ„¢ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).
This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpaceâ„¢ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InSpace implantation | Experimental | Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation |
|
| Tendon Repair | Active Comparator | Arthroscopic partial repair of rotator cuff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InSpace sub-acromial tissue spacer system | Device | Arthroscopic implantation of InSpace sub-acromial tissue spacer system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs. | The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful. | Baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24 | Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
Evidence of the following conditions:
The subject requires concomitant subscapularis repair and/or labral repair
Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
The subject's condition represents a worker's compensation case
The subject is currently involved in a health-related litigation procedure
Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study
Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period
The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
The subject currently has an acute infection in the area surrounding the surgical site.
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| Name | Affiliation | Role |
|---|---|---|
| Assaf Dekel, MD | Ortho-Space | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Orthopedic Institute | Van Nuys | California | 91405 | United States | ||
| University of Colorado |
Subjects excluded (n=45) for various reasons, not meeting criteria (n=11), declined to participate (n=12), and Other (n=22) such as, no medical clearance for surgery, intra-op screen failures, enrollment full.
Subjects assessed for eligibility n=229
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| ID | Title | Description |
|---|---|---|
| FG000 | InSpace Implantation | Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system |
| FG001 | Tendon Repair |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 26, 2018 |
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| Partial repair of rotator cuff | Procedure | Arthroscopic partial repair of rotator cuff |
|
| Baseline through to Month 24 |
| Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP) | The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). | Baseline to month 12 |
| Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP) | The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).. The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair. | Baseline to month 12 |
| Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC | The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair. | Baseline through to month 24 |
| Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES | Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24. The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful. | Baseline through to month 24 |
| Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair. | Baseline to month 24 |
| The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair. | Baseline through to month 24 |
| Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair. | Baseline through to month 24 |
| Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair. | Baseline through to month 24 |
| Denver |
| Colorado |
| 80222 |
| United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33334 | United States |
| Midwest Orthopedics at RUSH | Chicago | Illinois | 60612 | United States |
| Rockford Orthopedic Associates | Rockford | Illinois | 51107 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205-1911 | United States |
| MedStar Union Memorial Orthopaedics | Baltimore | Maryland | 21218 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02166 | United States |
| NYU | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Buffalo Buffalo | New York | New York | 14260 | United States |
| Upstate Orthopedics | Syracuse | New York | 13057 | United States |
| Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health | Cincinnati | Ohio | 45209 | United States |
| The Ohio State University | Ohio City | Ohio | 43210 | United States |
| Rothman Institute | Philadelphia | Pennsylvania | 19152 | United States |
| University Orthopedic Center | State College | Pennsylvania | 16801 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Fowler Kennedy Sport Medicine Clinic | London | Ontario | Canada |
| Roth McFarlane Hand and Upper Limb Center | London | Ontario | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | Canada |
Arthroscopic partial repair of rotator cuff
Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff
| COMPLETED |
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| NOT COMPLETED |
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Number of subjects who were randomized and received an InSpace implant and the number of subjects who received a Partial Repair of their rotator cuff.
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| ID | Title | Description |
|---|---|---|
| BG000 | InSpace Implantation | Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system |
| BG001 | Tendon Repair | Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs. | The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (≥275 points) and American Shoulder and Elbow Society (ASES) score (≥6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful. | Percentage of participants in the Per Protocol Population (PP) with surgical treatment success of the InSpace device as a Primary surgical treatment for Full-thickness massive rotator cuff tears (MRCT). | Posted | Number | percentage of participants | Baseline to month 12 |
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| Secondary | Composite Endpoint of WORC Improvement ≥275 and ASES Improvement ≥6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24 | Composite Endpoint Per Protocol Population (PP) of WORC Improvement ≥ 275 and ASES Improvement ≥ 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified). | Per Protocol Population with no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline through to Month 24 |
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| Secondary | Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP) | The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs). | Per Protocol Population | Posted | Number | percentage of participants | Baseline to month 12 |
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| Secondary | Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP) | The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).. The total score improvement of (≥ 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair. | Per Protocol Population | Posted | Number | percentage of participants | Baseline to month 12 |
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| Secondary | Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC | The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (≥275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair. | The Intent To Treat (ITT) population with available data. | Posted | Mean | Full Range | score on a scale | Baseline through to month 24 |
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| Secondary | Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES | Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24. The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful. | Intent To Treat (ITT) Population with available data | Posted | Mean | Full Range | score on a scale | Baseline through to month 24 |
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| Secondary | Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair. | Intent to Treat (ITT) Population with available data | Posted | Mean | Full Range | score on a scale | Baseline to month 24 |
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| Secondary | The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair. | Intent to Treat (ITT) Population with available data | Posted | Mean | Full Range | score on a scale | Baseline through to month 24 |
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| Secondary | Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair. | Intent To Treat (ITT) Population with available data | Posted | Mean | Full Range | score on a scale | Baseline through to month 24 |
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| Secondary | Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears | The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair. | Intent to Treat (ITT) Population with available data | Posted | Mean | Full Range | score on a scale | Baseline through to month 24 |
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Collected over 12 months and 24 months visit.
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
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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 | InSpace Implantation | Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation InSpace sub-acromial tissue spacer system: Arthroscopic implantation of InSpace sub-acromial tissue spacer system | 0 | 93 | 22 | 93 | 67 | 93 |
| EG001 | Tendon Repair | Arthroscopic partial repair of rotator cuff Partial repair of rotator cuff: Arthroscopic partial repair of rotator cuff | 1 | 91 | 22 | 91 | 69 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eg. Pain or inflammation | Musculoskeletal and connective tissue disorders | System Organ Class | Non-systematic Assessment | All body areas reported |
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| eg. dizziness, Aphasia, Cerebrovascular accident | Nervous system disorders | System Organ Class | Non-systematic Assessment |
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| eg.Prostate cancer, leukemia, Parathyroid tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | System Organ Class | Non-systematic Assessment |
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| eg. Multi-vessel Coronary Artery Disease | Cardiac disorders | System Organ Class | Non-systematic Assessment | Same subject can have more than one event. |
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| eg.Laryngeal granuloma, Chronic obstructive pulmonary disease, pulmonary mass | Respiratory, thoracic and mediastinal disorders | System Organ Class | Non-systematic Assessment |
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| eg. Gastrointestinal haemorrhage, short-bowel syndrome, small intestinal obstruction | Gastrointestinal disorders | System Organ Class | Non-systematic Assessment |
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| eg. Event leading to Death, non-cardiac chest pain, surgical failure | General disorders | System Organ Class | Non-systematic Assessment |
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| Angina Pectoris (Chest pain-Cardiac) | Cardiac disorders | System Organ Class | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | System Organ Class | Non-systematic Assessment | Same subject can have more than one event. |
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| Cardiac Arrest | Cardiac disorders | System Organ Class | Non-systematic Assessment | Same subject can have more than one event. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain, Arthralgia, back pain (anywhere in body) | Musculoskeletal and connective tissue disorders | System Organ Class | Non-systematic Assessment | Note: One subject may have more than one event in all of these categories. |
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| Fall and injury, meniscus injury, Tendon rupture (anywhere in body) | Injury, poisoning and procedural complications | System Organ Class | Non-systematic Assessment |
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| UTI, Bronchitis, pneumonia | Infections and infestations | System Organ Class | Non-systematic Assessment |
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| Headache, dizziness | Nervous system disorders | System Organ Class | Non-systematic Assessment |
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| Pain, Local swelling | General disorders | System Organ Class | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | System Organ Class | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | System Organ Class | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | System Organ Class | Non-systematic Assessment | Note: Some subjects may have more than one event. |
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| Tachycardia | Cardiac disorders | System Organ Class | Non-systematic Assessment |
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| Pre-Ventricular Contractions | Cardiac disorders | System Organ Class | Non-systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and can only extend the embargo with patent protection review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen Roden, Director, Clinical Operations | Stryker Company | 1 931 267 2041 | colleen.roden@stryker.com |
| May 19, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2018 | May 11, 2021 | ICF_001.pdf |
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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