INHANCE Stemless Reverse Shoulder IDE
Véletlenszerű, leendő, többközpontú vizsgálat az INHANCE szár nélküli teljes fordított vállrendszerről
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
There is one primary effectiveness endpoint and there are three primary safety endpoints:
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Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative
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Primary safety endpoint(s):
- No revision, removal, reoperation, supplemental fixation, or other intervention for any system component
- No humeral or glenoid radiolucent line >2 mm is present in 50% or more zones at 2 years
- 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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Florida
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Atlantis, Florida, Egyesült Államok, 33462
- Orthopedic Center of Palm Beach County
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Massachusetts
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Waltham, Massachusetts, Egyesült Államok, 02451
- Boston Bone & Joint Institute BBJI Formerly BSSC
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Michigan
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Grand Rapids, Michigan, Egyesült Államok, 49503
- Trinity Health Grand Rapids
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Missouri
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Columbia, Missouri, Egyesült Államok, 65201
- Missouri Orthopaedic Institute (MOI)
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North Carolina
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Charlotte, North Carolina, Egyesült Államok, 28207
- OrthoCarolina Research Institute Charlotte
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Raleigh, North Carolina, Egyesült Államok, 27609
- Duke Orthopaedics of Raleigh
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Ohio
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Akron, Ohio, Egyesült Államok, 44333
- Crystal Clinic Orthopaedic Center
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Cincinnati, Ohio, Egyesült Államok, 45219
- Lindner Research Center
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Cleveland, Ohio, Egyesült Államok, 44195
- The Cleveland Clinic Foundation
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Oregon
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Eugene, Oregon, Egyesült Államok, 97401
- Slocum Center for Orthopaedics and Sports Medicine
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Pennsylvania
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Bethlehem, Pennsylvania, Egyesült Államok, 18015
- St. Luke's University Health Network
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Philadelphia, Pennsylvania, Egyesült Államok, 19107
- Rothman Orthopaedics Institute
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Tennessee
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Columbia, Tennessee, Egyesült Államok, 38401
- MTBJ a division of Tennessee Orthaepedic Alliance
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Utah
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Salt Lake City, Utah, Egyesült Államok, 84108
- University of Utah
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Virginia
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Fredericksburg, Virginia, Egyesült Államok, 22408
- Mary Washington Orthopedics in affiliation with FOA
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).
- Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
- Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their information to DePuy Synthes.
- Individuals who are willing and able to return for follow-up as specified by the study protocol.
- Individuals who are a minimum age of 22 years at the time of consent.
- Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.
Exclusion Criteria:
- BMI > 40 kg/m2
- Individuals have active, uncontrolled local infection or systemic infection.
- Patients who have not reached skeletal maturity, regardless of age.
- Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment).
- Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
- Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
- Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.
- Revision of a failed hemi, total or reverse shoulder arthroplasty.
- Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.
- Individuals who are bedridden per the Investigator's determination.
- Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders).
- Patient has a medical condition with less than 2 years life expectancy.
- Patients who are known to be pregnant or breastfeeding.
- Known polyethylene and/or metal sensitivity or allergy.
- Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months
- Otherwise determined by the investigator to be medically unsuitable for participation in this study
- Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: INHANCE Stemless Reverse
INHANCE(TM) Stemless Reverse Total Shoulder |
Uncemented Reverse Total Shoulder |
|
Aktív összehasonlító: INHANCE Stemmed Reverse
INHANCE(TM) Stemmed Reverse Total Shoulder |
Uncemented Reverse Total Shoulder |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Constant Murley Score (CMS)
Időkeret: Pre-op, 2 years
|
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
Időkeret: 2 year
|
No removal of any system component |
2 year
|
|
Revision of any system component
Időkeret: 2 year
|
No revision of any system component |
2 year
|
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Reoperation of any system component
Időkeret: 2 year
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No reoperation of any system component |
2 year
|
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Supplemental Fixation of any system component
Időkeret: 2 year
|
No supplemental fixation of any system component |
2 year
|
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Radiolucent Lines (Humeral & Glenoid)
Időkeret: 2 year
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No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones |
2 year
|
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Migration and Tilt (Humeral & Glenoid)
Időkeret: 2 year
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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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Constant Murley Score (CMS)
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
|
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
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EQ-5D-5L and EQ-VAS
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
|
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
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Simple Shoulder Test
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
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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
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Single Assessment Numeric Evaluation (SANE) Score
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
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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
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Survivorship
Időkeret: 2 year
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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
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Complications
Időkeret: 2 year
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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
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Constant Murley Score (CMS)
Időkeret: Pre-op, 3-month, 6-month, 1 year
|
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
|
|
EQ-5D-5L and EQ-VAS
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
|
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
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
|
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
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
|
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
|
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Range of Motion
Időkeret: Pre-op, 3-month, 6-month, 1 year, 2 year
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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
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- DSM202108
- DSM202108 (Egyéb azonosító: DePuy Orthopaedics)
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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