Arthritis ShoulderNCT05297305
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty
A study testing Tornier Ascend Flex stem and Tornier Perform Stem Reverse+ in people with Arthritis Shoulder and Rotator Cuff Injuries, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Shoulder, Rotator Cuff Injuries
- What is being tested?
- Tornier Ascend Flex stem and Tornier Perform Stem Reverse+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary reverse total shoulder arthroplasty with the following components:
- 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
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial
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.
Read the 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.
- Conditions
- Arthritis Shoulder, Rotator Cuff Injuries
- Being tested
- Tornier Ascend Flex stem, Tornier Perform Stem Reverse+
- Keywords
- shoulder function, shoulder pain, shoulder range of motion
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tornier Ascend Flex stemDevice
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Tornier Perform Stem Reverse+Device
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)
| Study group | Role | What they receive |
|---|---|---|
| Onlay Component-Tornier Ascend Flex stem | Active comparator | Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus) Receives: Device: Tornier Ascend Flex stem |
| Inlay Component-Tornier Perform Stem Reverse+ | Active comparator | Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus) Receives: Device: Tornier Perform Stem Reverse+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active external rotation, 2 years
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Measured: 2 years postoperative
Secondary outcomes (52)
Active external rotation, 3 months
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Measured: 3 months postoperative
Active external rotation, 1 year
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Measured: 1 year postoperative
Strength during active external rotation, 3 months
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 3 months postoperative
Strength during active external rotation, 1 year
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 1 year postoperative
Strength during active external rotation, 2 years
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds
Measured: 2 years postoperative
Active forward elevation, 3 months
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Measured: 3 months postoperative
Active forward elevation, 1 year
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Measured: 1 year postoperative
Active forward elevation, 2 years
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Measured: 2 years postoperative
Strength during active forward elevation, 3 months
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 3 months postoperative
Strength during active forward elevation, 1 year
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 1 year postoperative
Strength during active forward elevation, 2 years
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 2 years postoperative
Abduction, 3 months
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Measured: 3 months postoperative
Abduction, 1 year
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Measured: 1 year postoperative
Abduction, 2 years
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Measured: 2 years postoperative
Strength during abduction, 3 months
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Measured: 3 months postoperative
Strength during abduction, 1 year
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Measured: 1 year postoperative
Strength during abduction, 2 years
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Measured: 2 years postoperative
Internal rotation, 3 months
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Measured: 3 months postoperative
Internal rotation, 1 year
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Measured: 1 year postoperative
Internal rotation, 2 years
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Measured: 2 years postoperative
Strength during Internal rotation, 3 months
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 3 months postoperative
Strength during Internal rotation, 1 year
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 1 year postoperative
Strength during Internal rotation, 2 years
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Measured: 2 years postoperative
External rotation lag sign test, 3 months
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
Measured: 3 months postoperative
External rotation lag sign test, 1 year
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness.
Measured: 1 year postoperative
External rotation lag sign test, 2 years
Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally A positive test indicates supraspinatus and infraspinatus tendon weakness.
Measured: 2 years postoperative
Drop arm test, 3 months
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Measured: 3 months postoperative
Drop arm test, 1 year
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Measured: 1 year postoperative
Drop arm test, 2 years
Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction.
Measured: 2 years postoperative
Lift off test, 3 months
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Measured: 3 months postoperative
Lift off test, 1 year
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Measured: 1 year postoperative
Lift off test, 2 years
Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness.
Measured: 2 years postoperative
Belly press test, 3 months
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Measured: 3 months postoperative
Belly press test, 1 year
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Measured: 1 year postoperative
Belly press test, 2 years
Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction.
Measured: 2 years postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Measured: 3 months postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year
Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Measured: 1 year postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years
Patients will complete a questionnaire of shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome).
Measured: 2 years postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Measured: 3 months postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Measured: 1 year postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years
Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome).
Measured: 2 years postoperative
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Measured: 3 months postoperative
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Measured: 1 year postoperative
Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years
Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome).
Measured: 2 years postoperative
Visual Analog Scale measure of pain, 3 months
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Measured: 3 months postoperative
Visual Analog Scale measure of pain, 1 year
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Measured: 1 year postoperative
Visual Analog Scale measure of pain, 2 years
Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome).
Measured: 2 years postoperative
Scapular notching, 3 months
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Measured: 3 months postoperative
Scapular notching, 1 year
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Measured: 1 year postoperative
Scapular notching, 2 years
Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome).
Measured: 2 years postoperative
Reoperation
Number of patients requiring reoperation of the same shoulder within 2 years.
Measured: 2 years postoperative
Study-related adverse events
All adverse events determined by the PI to be probably or definitely related to study interventions (surgery or device).
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start20 Oct 2023
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Why it stopped: Funding limitations and slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized double-blind trial of two active comparators.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Dr. Alex Martusiewicz, Corewell Health East
- Investigators
- Alex Martusiewicz, MD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297305
- Sponsor's protocol ID
- 2022-000
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05297305
- Acronym / sponsor ID
- 2022-000
- Conditions
- Arthritis Shoulder, Rotator Cuff Injuries
- Keywords
- shoulder function, shoulder pain, shoulder range of motion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding limitations and slow enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized double-blind trial of two active comparators.
| Arm | Type | Receives |
|---|---|---|
| Onlay Component-Tornier Ascend Flex stem | Active comparator | Device: Tornier Ascend Flex stemReverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus) |
| Inlay Component-Tornier Perform Stem Reverse+ | Active comparator | Device: Tornier Perform Stem Reverse+Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing primary reverse total shoulder arthroplasty with the following components:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tornier Ascend Flex stemReverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus) | Device | Onlay Component-Tornier Ascend Flex stem |
| Tornier Perform Stem Reverse+Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus) | Device | Inlay Component-Tornier Perform Stem Reverse+ |
Primary outcome
Active external rotation, 2 years
Time frame: 2 years postoperative
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
52 secondary outcomes
Active external rotation, 3 months
Time frame: 3 months postoperative
Active external rotation, 1 year
Time frame: 1 year postoperative
Strength during active external rotation, 3 months
Time frame: 3 months postoperative
Strength during active external rotation, 1 year
Time frame: 1 year postoperative
Strength during active external rotation, 2 years
Time frame: 2 years postoperative
Active forward elevation, 3 months
Time frame: 3 months postoperative
Active forward elevation, 1 year
Time frame: 1 year postoperative
Active forward elevation, 2 years
Time frame: 2 years postoperative
Strength during active forward elevation, 3 months
Time frame: 3 months postoperative
Strength during active forward elevation, 1 year
Time frame: 1 year postoperative
Strength during active forward elevation, 2 years
Time frame: 2 years postoperative
Abduction, 3 months
Time frame: 3 months postoperative
Abduction, 1 year
Time frame: 1 year postoperative
Abduction, 2 years
Time frame: 2 years postoperative
Strength during abduction, 3 months
Time frame: 3 months postoperative
Strength during abduction, 1 year
Time frame: 1 year postoperative
Strength during abduction, 2 years
Time frame: 2 years postoperative
Internal rotation, 3 months
Time frame: 3 months postoperative
Internal rotation, 1 year
Time frame: 1 year postoperative
Internal rotation, 2 years
Time frame: 2 years postoperative
Strength during Internal rotation, 3 months
Time frame: 3 months postoperative
Strength during Internal rotation, 1 year
Time frame: 1 year postoperative
Strength during Internal rotation, 2 years
Time frame: 2 years postoperative
External rotation lag sign test, 3 months
Time frame: 3 months postoperative
External rotation lag sign test, 1 year
Time frame: 1 year postoperative
External rotation lag sign test, 2 years
Time frame: 2 years postoperative
Drop arm test, 3 months
Time frame: 3 months postoperative
Drop arm test, 1 year
Time frame: 1 year postoperative
Drop arm test, 2 years
Time frame: 2 years postoperative
Lift off test, 3 months
Time frame: 3 months postoperative
Lift off test, 1 year
Time frame: 1 year postoperative
Lift off test, 2 years
Time frame: 2 years postoperative
Belly press test, 3 months
Time frame: 3 months postoperative
Belly press test, 1 year
Time frame: 1 year postoperative
Belly press test, 2 years
Time frame: 2 years postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months
Time frame: 3 months postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year
Time frame: 1 year postoperative
Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years
Time frame: 2 years postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months
Time frame: 3 months postoperative
Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year
Time frame: 1 year postoperative
Results and safety
The study was stopped early (reason given: Funding limitations and slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Martusiewicz, MD principal investigator
Beaumont Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tornier Ascend Flex stem and Tornier Perform Stem Reverse+ in people with Arthritis Shoulder and Rotator Cuff Injuries, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding limitations and slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active external rotation, 2 years (time frame: 2 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.