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: 1. Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative 2. Primary safety endpoint(s): 1. No revision, removal, reoperation, supplemental fixation, or other intervention for any system component 2. No humeral or glenoid radiolucent line \>2 mm is present in 50% or more zones at 2 years 3. No conclusive evidence of migration and tilt (\>5mm migration and \>10° tilt) of the humeral or glenoid component at 2 years 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Uncemented Reverse Total Shoulder
Hoag Orthopedic Institute
Irvine, California, United States
WITHDRAWNConstant 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.
Time frame: Pre-op, 2 years
Removal of any system component
No removal of any system component
Time frame: 2 year
Revision of any system component
No revision of any system component
Time frame: 2 year
Reoperation of any system component
No reoperation of any system component
Time frame: 2 year
Supplemental Fixation of any system component
No supplemental fixation of any system component
Time frame: 2 year
Radiolucent Lines (Humeral & Glenoid)
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
Time frame: 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
Time frame: 2 year
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cedars Sinai Medical Center
Los Angeles, California, United States
NOT_YET_RECRUITINGOrthopedic Center of Palm Beach County
Atlantis, Florida, United States
RECRUITINGBoston Bone & Joint Institute BBJI Formerly BSSC
Waltham, Massachusetts, United States
NOT_YET_RECRUITINGTrinity Health Grand Rapids
Grand Rapids, Michigan, United States
RECRUITINGMissouri Orthopaedic Institute (MOI)
Columbia, Missouri, United States
RECRUITINGOrthoCarolina Research Institute Charlotte
Charlotte, North Carolina, United States
RECRUITINGDuke Orthopaedics of Raleigh
Raleigh, North Carolina, United States
NOT_YET_RECRUITINGCrystal Clinic Orthopaedic Center
Akron, Ohio, United States
RECRUITINGLindner Research Center
Cincinnati, Ohio, United States
RECRUITING...and 8 more locations
Time frame: Pre-op, 3-month, 6-month, 1 year, 2 year
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).
Time frame: 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).
Time frame: 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".
Time frame: 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.
Time frame: 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
Time frame: 2 year