INHANCE Stemless Reverse Shoulder IDE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorDePuy Orthopaedics
About this trial
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Reverse Total Shoulder
DeviceUncemented Reverse Total Shoulder
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: INHANCE Stemless ReverseExperimental treatment 1 intervention
Group B: INHANCE Stemmed ReverseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-op, 2 years2
Removal of any system component
No removal of any system component
Time frame
2 year3
Revision of any system component
No revision of any system component
Time frame
2 year4
Reoperation of any system component
No reoperation of any system component
Time frame
2 yearSecondary outcomes
1
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.
Time frame
Pre-op, 3-month, 6-month, 1 year, 2 year2
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 year3
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 year4
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 yearOther outcomes
1
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.
Time frame
Pre-op, 3-month, 6-month, 1 year2
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).
Time frame
Pre-op, 3-month, 6-month, 1 year, 2 year3
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).
Time frame
Pre-op, 3-month, 6-month, 1 year, 2 year4
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".
Time frame
Pre-op, 3-month, 6-month, 1 year, 2 yearSponsors and contacts
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Source ClinicalTrials.gov