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| ID | Type | Description | Link |
|---|---|---|---|
| DSM202108 | Other Identifier | DePuy Orthopaedics |
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2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
There is one primary effectiveness endpoint and there are three primary safety endpoints:
Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative
Primary safety endpoint(s):
The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INHANCE Stemless Reverse | Experimental | INHANCE(TM) Stemless Reverse Total Shoulder |
|
| INHANCE Stemmed Reverse | Active Comparator | INHANCE(TM) Stemmed Reverse Total Shoulder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reverse Total Shoulder | Device | Uncemented Reverse Total Shoulder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constant Murley Score (CMS) | Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score. | Pre-op, 2 years |
| Removal of any system component | No removal of any system component | 2 year |
| Revision of any system component | No revision of any system component | 2 year |
| Reoperation of any system component | No reoperation of any system component | 2 year |
| Supplemental Fixation of any system component | No supplemental fixation of any system component | 2 year |
| Radiolucent Lines (Humeral & Glenoid) | No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones | 2 year |
| Migration and Tilt (Humeral & Glenoid) | No conclusive evidence of migration and tilt (greater than 5mm migration and greater than 10 degrees tilt) of the humeral or glenoid component | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Murley Score (CMS) | Adjusted Constant-Murley Score at baseline and 3- and 6-months and 1- and 2-years post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score. | Pre-op, 3-month, 6-month, 1 year, 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Murley Score (CMS) | Change from baseline adjusted Constant-Murley Score at 3- and 6-months and 1- year post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score. | Pre-op, 3-month, 6-month, 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 574-404-7996 | dfawley1@its.jnj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Orthopedic Institute | Withdrawn | Irvine | California | 92618 | United States | |
| Cedars Sinai Medical Center |
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2:1 Randomized (Stemless to Stemmed)
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| EQ-5D-5L and EQ-VAS |
EQ-5D-5L Scores by dimension and EQ-VAS, at baseline and 3- and 6-months and 1- and 2-years post-operative. The value score generally ranges from less than 0 to 1, with higher scores indicating higher health utility. The EQ VAS records the subject's self-rated health from 0 (worst) to 100 (best). |
| Pre-op, 3-month, 6-month, 1 year, 2 year |
| Simple Shoulder Test | Simple Shoulder Test (SST) Scores at baseline and 3- and 6-months and 1- and 2-years post-operative. Scores range from 0 (worst) to 12 (best). | Pre-op, 3-month, 6-month, 1 year, 2 year |
| Single Assessment Numeric Evaluation (SANE) Score | Single Assessment Numeric Evaluation (SANE) Scores at baseline and 3- and 6-months and 1- and 2-years post-operative. The scale is 0 to 100 with 100 being "normal". | Pre-op, 3-month, 6-month, 1 year, 2 year |
| Survivorship | Overall survivorship of the INHANCE Shoulder System at 2 years post-operative, where the system is deemed to be surviving if no components (humeral stem or stemless component, glenosphere, baseplate, liner, etc.) have been removed for any reason, will be presented using the Kaplan-Meier method. | 2 year |
| Complications | The type and frequency of all reportable adverse events (AEs) and device deficiencies in this study will be summarized, with distinction of serious AEs, device and procedure related AEs | 2 year |
| EQ-5D-5L and EQ-VAS |
Change from baseline EQ-5D-5L Value Score and EQ-VAS, at 3- and 6-months and 1- and 2-years post-operative. The value score generally ranges from less than 0 to 1, with higher scores indicating higher health utility. The EQ VAS records the subject's self-rated health from 0 (worst) to 100 (best). |
| Pre-op, 3-month, 6-month, 1 year, 2 year |
| Simple Shoulder Test | Change from baseline SST Scores at 3- and 6-months and 1- and 2-years post-operative. Scores range from 0 (worst) to 12 (best). | Pre-op, 3-month, 6-month, 1 year, 2 year |
| Single Assessment Numeric Evaluation (SANE) Score | Change from baseline SANE Scores at 3- and 6-months and 1- and 2-years post-operative. The scale is 0 to 100 with 100 being "normal". | Pre-op, 3-month, 6-month, 1 year, 2 year |
| Range of Motion | Change from baseline range of motion at 3- and 6-months and 1- and 2-years post-operative | Pre-op, 3-month, 6-month, 1 year, 2 year |
| Not yet recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
| Orthopedic Center of Palm Beach County | Recruiting | Atlantis | Florida | 33462 | United States |
| Hospital for Special Surgery | Not yet recruiting | West Palm Beach | Florida | 33401 | United States |
| Boston Bone & Joint Institute BBJI Formerly BSSC | Recruiting | Waltham | Massachusetts | 02451 | United States |
| Trinity Health Grand Rapids | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Missouri Orthopaedic Institute (MOI) | Recruiting | Columbia | Missouri | 65201 | United States |
| OrthoCarolina Research Institute Charlotte | Recruiting | Charlotte | North Carolina | 28207 | United States |
| Duke Orthopaedics of Raleigh | Recruiting | Raleigh | North Carolina | 27609 | United States |
| Crystal Clinic Orthopaedic Center | Recruiting | Akron | Ohio | 44333 | United States |
| Lindner Research Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| Slocum Center for Orthopaedics and Sports Medicine | Recruiting | Eugene | Oregon | 97401 | United States |
| St. Luke's University Health Network | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
| Rothman Orthopaedics Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| MTBJ a division of Tennessee Orthaepedic Alliance | Recruiting | Columbia | Tennessee | 38401 | United States |
| TOSH- The Orthopedic Specialty Hospital | Withdrawn | Murray | Utah | 84107 | United States |
| University of Utah | Recruiting | Salt Lake City | Utah | 84108 | United States |
| Mary Washington Orthopedics in affiliation with FOA | Not yet recruiting | Fredericksburg | Virginia | 22408 | United States |