Shoulder OsteoarthritisNCT06319911
AETOS Shoulder System
An observational study of Shoulder Osteoarthritis and Shoulder Arthritis, run by Smith & Nephew, Inc. at 5 sites in United States.
Trial summary
The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Osteoarthritis, Shoulder Arthritis
- What is being tested?
- AETOS
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Mar 2024to 30 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Males and females who are at least 18 years of age at the time of consent, are skeletally mature, and are indicated for primary anatomic or primary reverse will be enrolled in the study
Who may be able to join
- Patients must meet all the following criteria to be included in the study:
- Patient is at least 18 years of age at the time of consent and skeletally mature.
- Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications:
- Rheumatoid arthritis, and/or
- Traumatic arthritis (Post Traumatic arthritis), and/or
- Non-inflammatory degenerative joint disease, and/or
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- Correction of functional deformity.
- Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \& cooperate in the standard of care post-operative therapy.
- Patient is geographically stable and willing to return to the study site for all follow-up visits.
- Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.
- -
Who cannot join
- Patients who meet any of the following criteria will not qualify for participation in the trial:
- Patient has a contraindication to AETOS.
- Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
- Patient is indicated for a Hemiarthroplasty.
- Patient has traumatic injury or a fracture.
- Patient has uncontrolled diabetes with a hemoglobin A1C of 7.5 or greater.
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- Patient has comorbidities/conditions that preclude proper healing/fixation of the implant.
- Patient has poor quality or insufficient bone stock to support the implant.
- Patient has poor bone quality where there could be considerable migration of the implant and/or a chance of fracture.
- Patient has rapid joint destruction, marked bone loss or bone resorption (e.g., severe osteoporosis).
- Patient has osteomalacia.
- Patient has muscular, neurologic, or vascular deficiencies that may compromise the outcome of the shoulder replacement surgery.
- Patient has a known sensitivity, allergic reaction, and/or known allergies to one or more of the implanted materials.
- Patient has a distant foci of infection which may spread to the implant site, active local or systemic infection, sepsis, or osteomyelitis.
- Patient has an elevation of sedimentation rate, elevation of WBC count, or marked shift in WBC differential count unexplained by other disease.
- If reverse shoulder arthroplasty, patient has a non-functional deltoid or external rotator muscles.
- If reverse shoulder arthroplasty, patient has a significant injury to the upper brachial plexus.
- If reverse shoulder arthroplasty, patient has paralysis of the axillary nerve.
- Patient is uncooperative, has a neurologic disorder and is not capable of following directions, or is a vulnerable subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
- Patient is pregnant or plans to become pregnant during the follow-up period.
- Patient has a Body Mass Index (BMI) of >35kg/m2 or a BMI that may compromise the outcome of the shoulder replacement surgery.
- Patient has anticipated activities which would impose high stresses on the implant and its fixation or has a high likelihood of a fall.
- Patient is a known smoker, vaper, alcohol abuser, or drug abuser within 180 days of consent.
- Patient has participated previously in this clinical trial and was withdrawn.
- Patient is participating in another device or drug trial or observational competitive study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Center for Orthopedics and Neurosurgical Care
Bend, Oregon, 97701
Cody Manriquez, 541-420-0774, codymanriquez@gmail.com
Scott Jacobson, MD
- Recruiting
Hughston Foundation
Columbus, Georgia, 31909
Cholly Minton, 706-494-3330, cminton@hughston.com
Brent Ponce
- Recruiting
Western Orthopaedics
Denver, Colorado, 80210
Libby Mauter, 303-321-1333, lmauter@western-ortho.com
Armand Hatzidakis
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
Brooke Olin, 267-516-9393
Matthew Ramsey, MD
- Recruiting
California Pacific Orthopedics
San Francisco, California, 94118
Katie Sheehi, 415-668-8010, ksheehi@calpacortho.com
James Kelly, MD
About this study
Official title: AETOS Shoulder System Post Market Clinical Investigation
The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization
Read the detailed description
This study will confirm the safety and performance of the AETOS Shoulder System in anatomic and reverse TSA. Revisions will not be enrolled into this study.
The AETOS Shoulder System is manufactured by Smith \& Nephew, Inc., 1450 Brooks Road Memphis, Tennessee 38116 USA, and has been 510k Cleared as of 07Jun2023; therefore, it is considered a post-market product and will be procured through normal commercial channels in the USA. The humeral stem is designed to be used for both Total Shoulder Arthroplasty (TSA) and reverse shoulder arthroplasty procedures. The humeral stems are designed with fins and a porous plasma coating to provide fixation within the proximal humeral metaphysis.
- Conditions
- Shoulder Osteoarthritis, Shoulder Arthritis
- Being tested
- AETOS
- Keywords
- Shoulder, arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AETOSDevice
The AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration
| Study group | Role | What they receive |
|---|---|---|
| Primary Anatomic | Those subjects who have the AETOS implanted in the Primary Anatomic configuration Receives: Device: AETOS | |
| Primary reverse | Those subjects who have AETOS implanted in the Reverse configuration Receives: Device: AETOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component
Measured: 2 years
Secondary outcomes (14)
Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years
Implant Survivorship at 6 months, 1 year, 3.5 years, and 5 years defined as absence of device removal or revision of any component
Measured: 6 months, 1 year, 3.5 years, and 5 years
Radiographic Assessment - Glenoid Migration/Subsidence
Glenoid Component Migration / Subsidence collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions:
- Absent: No evidence of glenoid component displacement ≥ 5 mm relative to the native bone stock.
- Present: Presence of glenoid component displacement ≥ 5 mm relative to the native bone stock.
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Glenoid Radiolucency
Glenoid Component Radiolucency - antero-posterior (AP) collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions:
- Absent: No evidence of radiolucency > 2 mm in width along the bone-implant / bone-cement interface in any zone.
- Present: Presence of radiolucency > 2 mm in width along the bone-implant / bone-cement interface in one or more zones.
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Radiolucency
Humeral Component Radiolucency - AP collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions:
- Absent: No evidence of radiolucency > 2 mm in width along the bone-implant interface in any zone.
- Present: Presence of radiolucency > 2 mm in width along the bone-implant interface in one or more zones.
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Migration/Subsidence
Humeral Component Migration / Subsidence collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions:
- Absent: No evidence of a change in position of the humeral component relative to the native bone stock ≥ 5 mm.
- Present: Presence of a change in position of the humeral component relative to the native bone stock ≥ 5 mm
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Head Centeredness
Humeral Head Centeredness collected post-surgery at day 0, 1 year, 2 years, and 5 years will be calculated using the method described by Iannotti and Norris from the axillary view
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Bone Remodeling
Bone Remodeling of the humerus collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions by Schnetzke et al.:
- Absent: No evidence of humerus bone remodeling.
- Present: Presence of one or more features of humerus bone remodeling.
- 1. Condensation Lines: Presence of condensation lines around the tip of the stem.
- 2. Cortical Thinning: Presence of cortical thinning and osteopenia.
- 3. Spot Welds: Presence of spot welds.
- 4. Other: Other feature not listed above.
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Glenohumeral Subluxation
Glenohumeral Subluxation collected post-surgery at day 0, 1 year, 2 years, and 5 years will be will be derived from the Humeral Head Centeredness assessment using the following definitions, from Iannotti and Norris et al.:
- Absent: Humeral Head Centeredness is ≤25%.
- Present: Humeral Head Centeredness is >25%.
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Device Condition: Anatomic
Device Condition - Anatomic collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions:
- Intact: No evidence of fracture, breakage, loosening, disassembly or migration of any of the components of the anatomic AETOS TSA.
- Not Intact: Presence of fracture, breakage, loosening, disassembly or migration of one or more of the components of the anatomic AETOS TSA:
- 1. Humeral Stem.
- 2. Humeral Head.
- 3. Glenoid.
- 4. Post Extension.
Measured: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Device Condition: Reverse
Device Condition - Reverse collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions:
- Intact: No evidence of fracture, breakage, loosening, disassembly or migration of any of the components of the reverse AETOS TSA.
- Not Intact: Presence of fracture, breakage, loosening, disassembly or migration of one or more of the components of the reverse AETOS TSA:
- 1. Humeral Stem.
- 2. Reverse Liner.
- 3. Glenosphere.
- 4. Metal Glenoid.
- 5. Peripheral Screws.
- 6. Central Screw.
- 7. Humeral Spacer.
- 8. Post Extension.
Measured: Day 0, 1 year, 2 years, and 5 years
American Shoulder and Elbow Score (ASES)
The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating with a higher score indicating improvement in pain and function.
Measured: 6 months, 1 year, 2 years, and 5 years
Constant Murley Score
Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the subject; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
Measured: 6 months, 1 year, 2 years, and 5 years
Simple Shoulder Test (SST)
Series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answer to these questions provides a standardized way of recording the function of a shoulder before and after treatment.
Measured: 6 months, 1 year, 2 years, and 5 years
Single Assessment Numeric Evaluation (SANE)
The SANE is a simple, single-question, patient-based shoulder function assessment tool: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''
Measured: 6 months, 1 year, 2 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start5 Mar 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kolja Boese, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319911
- Sponsor's protocol ID
- AETOS 2022.04
- Status last verified
- May 2024
- First submitted
- 28 Feb 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AETOS Shoulder System Post Market Clinical Investigation
- ClinicalTrials.gov ID
- NCT06319911
- Acronym / sponsor ID
- AETOS 2022.04
- Conditions
- Shoulder Osteoarthritis, Shoulder Arthritis
- Keywords
- Shoulder, arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 20 Mar 2024 (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 confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization
Detailed description
This study will confirm the safety and performance of the AETOS Shoulder System in anatomic and reverse TSA. Revisions will not be enrolled into this study.
The AETOS Shoulder System is manufactured by Smith \& Nephew, Inc., 1450 Brooks Road Memphis, Tennessee 38116 USA, and has been 510k Cleared as of 07Jun2023; therefore, it is considered a post-market product and will be procured through normal commercial channels in the USA. The humeral stem is designed to be used for both Total Shoulder Arthroplasty (TSA) and reverse shoulder arthroplasty procedures. The humeral stems are designed with fins and a porous plasma coating to provide fixation within the proximal humeral metaphysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Anatomic | – | Device: AETOSThose subjects who have the AETOS implanted in the Primary Anatomic configuration |
| Primary reverse | – | Device: AETOSThose subjects who have AETOS implanted in the Reverse configuration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females who are at least 18 years of age at the time of consent, are skeletally mature, and are indicated for primary anatomic or primary reverse will be enrolled in the study
Key inclusion criteria (11 listed)
- Patient is at least 18 years of age at the time of consent and skeletally mature.
- Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications:
- Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \& cooperate in the standard of care post-operative therapy.
- Patient is geographically stable and willing to return to the study site for all follow-up visits.
- Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.
Key exclusion criteria (25 listed)
- Patients who meet any of the following criteria will not qualify for participation in the trial:
- Patient has a contraindication to AETOS.
- Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
- Patient is indicated for a Hemiarthroplasty.
- Patient has traumatic injury or a fracture.
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 |
|---|---|---|
| AETOSThe AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration | Device | Primary Anatomic, Primary reverse |
Primary outcome
Implant Survivorship
Time frame: 2 years
Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component
14 secondary outcomes
Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years
Time frame: 6 months, 1 year, 3.5 years, and 5 years
Radiographic Assessment - Glenoid Migration/Subsidence
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Glenoid Radiolucency
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Radiolucency
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Migration/Subsidence
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Humeral Head Centeredness
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Bone Remodeling
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Glenohumeral Subluxation
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Device Condition: Anatomic
Time frame: Day 0, 1 year, 2 years, and 5 years
Radiographic Assessment - Device Condition: Reverse
Time frame: Day 0, 1 year, 2 years, and 5 years
American Shoulder and Elbow Score (ASES)
Time frame: 6 months, 1 year, 2 years, and 5 years
Constant Murley Score
Time frame: 6 months, 1 year, 2 years, and 5 years
Simple Shoulder Test (SST)
Time frame: 6 months, 1 year, 2 years, and 5 years
Single Assessment Numeric Evaluation (SANE)
Time frame: 6 months, 1 year, 2 years, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
Kolja Boese study director
Smith & Nephew, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Osteoarthritis and Shoulder Arthritis, run by Smith & Nephew, Inc. at 5 sites 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 11 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tammy Clark, MPH (3512269585, tammy.clark@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship (time frame: 2 years). 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 7 May 2024.