Clinical trial NCT05297305: Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
Official title: Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis Shoulder
Rotator Cuff Injuries
Keywords: shoulder function
shoulder pain
shoulder range of motion
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2022-03-28
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized double-blind trial of two active comparators.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.

Detailed description: This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary reverse total shoulder arthroplasty with the following components:

  1. Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
  2. Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere
* Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear
* Negative external rotation lag sign, ability to externally rotate beyond neutral
* Age 18 years or older

Exclusion Criteria:

* Revision arthroplasty
* Prior open shoulder surgery
* Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius)
* Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
* Patients not willing to undergo a standardized physical therapy protocol or home therapy program after surgical intervention
* Patient anatomy does not accommodate the study implants per surgeon discretion
* Pregnant, patient-reported
* Minors (under 18 years of age)
* Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires

Primary outcomes:
measure: Active external rotation, 2 years
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Active external rotation, 3 months
timeFrame: 3 months postoperative
measure: Active external rotation, 1 year
timeFrame: 1 year postoperative
measure: Strength during active external rotation, 3 months
timeFrame: 3 months postoperative
measure: Strength during active external rotation, 1 year
timeFrame: 1 year postoperative
measure: Strength during active external rotation, 2 years
timeFrame: 2 years postoperative
measure: Active forward elevation, 3 months
timeFrame: 3 months postoperative
measure: Active forward elevation, 1 year
timeFrame: 1 year postoperative
measure: Active forward elevation, 2 years
timeFrame: 2 years postoperative
measure: Strength during active forward elevation, 3 months
timeFrame: 3 months postoperative
measure: Strength during active forward elevation, 1 year
timeFrame: 1 year postoperative
measure: Strength during active forward elevation, 2 years
timeFrame: 2 years postoperative
measure: Abduction, 3 months
timeFrame: 3 months postoperative
measure: Abduction, 1 year
timeFrame: 1 year postoperative
measure: Abduction, 2 years
timeFrame: 2 years postoperative
measure: Strength during abduction, 3 months
timeFrame: 3 months postoperative
measure: Strength during abduction, 1 year
timeFrame: 1 year postoperative
measure: Strength during abduction, 2 years
timeFrame: 2 years postoperative
measure: Internal rotation, 3 months
timeFrame: 3 months postoperative
measure: Internal rotation, 1 year
timeFrame: 1 year postoperative
measure: Internal rotation, 2 years
timeFrame: 2 years postoperative
measure: Strength during Internal rotation, 3 months
timeFrame: 3 months postoperative
measure: Strength during Internal rotation, 1 year
timeFrame: 1 year postoperative
measure: Strength during Internal rotation, 2 years
timeFrame: 2 years postoperative
measure: External rotation lag sign test, 3 months
timeFrame: 3 months postoperative
measure: External rotation lag sign test, 1 year
timeFrame: 1 year postoperative
measure: External rotation lag sign test, 2 years
timeFrame: 2 years postoperative
measure: Drop arm test, 3 months
timeFrame: 3 months postoperative
measure: Drop arm test, 1 year
timeFrame: 1 year postoperative
measure: Drop arm test, 2 years
timeFrame: 2 years postoperative
measure: Lift off test, 3 months
timeFrame: 3 months postoperative
measure: Lift off test, 1 year
timeFrame: 1 year postoperative
measure: Lift off test, 2 years
timeFrame: 2 years postoperative
measure: Belly press test, 3 months
timeFrame: 3 months postoperative
measure: Belly press test, 1 year
timeFrame: 1 year postoperative
measure: Belly press test, 2 years
timeFrame: 2 years postoperative
measure: Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months
timeFrame: 3 months postoperative
measure: Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year
timeFrame: 1 year postoperative
measure: Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years
timeFrame: 2 years postoperative
measure: Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months
timeFrame: 3 months postoperative
measure: Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year
timeFrame: 1 year postoperative
measure: Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years
timeFrame: 2 years postoperative
measure: Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months
timeFrame: 3 months postoperative
measure: Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year
timeFrame: 1 year postoperative
measure: Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years
timeFrame: 2 years postoperative
measure: Visual Analog Scale measure of pain, 3 months
timeFrame: 3 months postoperative
measure: Visual Analog Scale measure of pain, 1 year
timeFrame: 1 year postoperative
measure: Visual Analog Scale measure of pain, 2 years
timeFrame: 2 years postoperative
measure: Scapular notching, 3 months
timeFrame: 3 months postoperative
measure: Scapular notching, 1 year
timeFrame: 1 year postoperative
measure: Scapular notching, 2 years
timeFrame: 2 years postoperative
measure: Reoperation
timeFrame: 2 years postoperative
measure: Study-related adverse events
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: Beaumont Health
name: Alex Martusiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: