Rotator Cuff Tear ArthropathySubscapNCT05438914
Subscapularis Repair in Reverse Shoulder Arthroplasty
A study testing Repair of the subscapularis in people with Rotator Cuff Tear Arthropathy, run by Arthrex, Inc. at 6 sites in United States.
Trial summary
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rotator Cuff Tear Arthropathy
- What is being tested?
- Repair of the subscapularis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Nov 2022to 14 Sep 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- Patient meets FDA cleared indications for reverse shoulder arthroplasty
- Patient is between 18-100 years old
- Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
- Patient has a standard of care pre-operative CT taken within 6 months that has been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning
Who cannot join
- Patient has a history of ipsilateral shoulder arthroplasty
- A history of shoulder septic arthritis
- A full thickness subscapularis tear
- An acute or malunited proximal humeral fracture
- Chronic locked dislocation
- Rheumatoid arthritis
Show all 16Show fewer
- Tumors
- Axillary nerve damage
- Non-functioning deltoid muscle
- Glenoid vault deficiency precluding baseplate fixation
- Infection and neuropathic joints
- Known or suspected non-compliance, drug or alcohol abuse
- Patients incapable of judgement or under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
- The subject is related to investigator as family members, employees, or other dependent persons
- Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
The Campbell Clinic
Collierville, Tennessee, 38017
Margaret Knack
- Not yet recruiting
Western Orthopaedics, P.C.
Denver, Colorado, 80218
Mallory Boyd, mboyd@western-ortho.com
Benjamin Sears, MD
- Recruiting
The Hawkins Foundation
Greenville, South Carolina, 29615
Sam Pergiovanni, 888-666-2904
Michael Kissenberth, MD
- Recruiting
Southern Oregon Orthopedics
Medford, Oregon, 97504
Patrick Denard, MD
- Recruiting
Jordan Young Institute
Norfolk, Virginia, 23462
Amanda Firoved
- Recruiting
The University of Arizona/Banner Health
Phoenix, Arizona, 85006
Saleh Ahmed
About this study
Official title: Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
Read the detailed description
The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.
Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.
- Conditions
- Rotator Cuff Tear Arthropathy
- Being tested
- Repair of the subscapularis
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of the subscapularisDevice
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| Reverse Shoulder Arthroplasty with subscapularis repair | Experimental | The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique. Receives: Device: Repair of the subscapularis |
| Reverse Shoulder Arthroplasty without subscapularis repair | No intervention | The subscapularis will not be repaired. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Measured: Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Measured: Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Measured: Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Measured: Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
Constant-Murley Shoulder Outcome Score
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Measured: Collected at the 2 year post-op timepoint, and is the primary outcome measure
Secondary outcomes (10)
Ultrasound
Evaluation of the subscapularis complex in patients that have been randomized to "repair of the subscapularis" to examine the subscapularis complex. Ultrasound scans will be read and the integrity of the subscapularis complex will be determined by the clinician to be "intact", "attenuated", "partial tear" or "complete tear".
Measured: Collected once at either the 6 month, 1 year or 2 year timepoint.
American Shoulder and Elbow Surgeons (ASES) subjective survey
A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.
Measured: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Simple Shoulder Test (SST) questionnaire
Provides a standardized way of recording the function of a shoulder before and after treatment.
Measured: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Visual Analog Scale (VAS)
The standard measure for pain on a 0-10 scale, 10 being the worst.
Measured: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
A patient administrated questionnaire for measurement of the quality of life. It provides scores on four domains: 1.) physical symptoms, 2.) sport, recreation, and work, 3.) lifestyle and 4.) emotions.
Measured: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Veterans Rand 12 Item Health Survey (VR-12)
A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.
Measured: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Single Assessment Numeric Evaluation score (SANE)
Asks patients to rate shoulder pain as a percentage of normal.
Measured: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Standard Pre-Operative Form
A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure.
Measured: Collected at the pre-op visit.
Return to Work Form
A patient administered form that asks patients to determine the effect that their shoulder has had on their employment.
Measured: Collected at pre-op, 26 weeks and 1 year.
Standard Late Postoperative Form
A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure.
Measured: Collected at the 1 year and 2 year timepoints.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start14 Nov 2022
- Primary completion14 Sep 2025 (estimated)
- Study completion14 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438914
- Sponsor's protocol ID
- AIRR-00608-20
- Acronym
- Subscap
- Status last verified
- Jan 2024
- First submitted
- 19 May 2022
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT05438914
- Acronym / sponsor ID
- Subscap / AIRR-00608-20
- Conditions
- Rotator Cuff Tear Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 Sep 2025 (estimated)
- Study completion
- 14 Sep 2025 (estimated)
- First posted
- 30 Jun 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.
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
Detailed description
The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.
Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomly allocated in a 1:1 ratio, with block sizes of four and six using a randomization sequence.
| Arm | Type | Receives |
|---|---|---|
| Reverse Shoulder Arthroplasty with subscapularis repair | Experimental | Device: Repair of the subscapularisThe subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique. |
| Reverse Shoulder Arthroplasty without subscapularis repair | No intervention | –The subscapularis will not be repaired. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
- Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
- Patient meets FDA cleared indications for reverse shoulder arthroplasty
- Patient is between 18-100 years old
- Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
Key exclusion criteria (16 listed)
- Patient has a history of ipsilateral shoulder arthroplasty
- A history of shoulder septic arthritis
- A full thickness subscapularis tear
- An acute or malunited proximal humeral fracture
- Chronic locked dislocation
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 |
|---|---|---|
| Repair of the subscapularisThe subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique. | Device | Reverse Shoulder Arthroplasty with subscapularis repair |
Primary outcome
Constant-Murley Shoulder Outcome Score
Time frame: Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
Time frame: Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
Time frame: Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
Time frame: Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure.
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
Constant-Murley Shoulder Outcome Score
Time frame: Collected at the 2 year post-op timepoint, and is the primary outcome measure
A combination of objective measures and patient-reported outcomes. It defines the level of pain and the ability to carry out the normal daily activities of the patient. It is a 0-100 point scale, the higher the score, the higher the quality of the function.
10 secondary outcomes
Ultrasound
Time frame: Collected once at either the 6 month, 1 year or 2 year timepoint.
American Shoulder and Elbow Surgeons (ASES) subjective survey
Time frame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Simple Shoulder Test (SST) questionnaire
Time frame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Visual Analog Scale (VAS)
Time frame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time frame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Veterans Rand 12 Item Health Survey (VR-12)
Time frame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Single Assessment Numeric Evaluation score (SANE)
Time frame: Collected at pre-op, 9 weeks, 26 weeks, 1 year and 2 year post-op timepoints.
Standard Pre-Operative Form
Time frame: Collected at the pre-op visit.
Return to Work Form
Time frame: Collected at pre-op, 26 weeks and 1 year.
Standard Late Postoperative Form
Time frame: Collected at the 1 year and 2 year timepoints.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 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. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of the subscapularis in people with Rotator Cuff Tear Arthropathy, run by Arthrex, Inc. at 6 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly A Ganz (1 (800) 933-7001 ext. 71119, kelly.ganz@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Shoulder Outcome Score (time frame: Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.). The study lists 5 primary outcomes in all. 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 30 Jan 2024.