Subscapularis Repair in Reverse Shoulder Arthroplasty (Subscap)

January 29, 2024 updated by: Arthrex, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • The University of Arizona/Banner Health
        • Contact:
          • Saleh Ahmed
    • Colorado
      • Denver, Colorado, United States, 80218
        • Not yet recruiting
        • Western Orthopaedics, P.C.
        • Contact:
        • Principal Investigator:
          • Benjamin Sears, MD
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Southern Oregon Orthopedics
        • Contact:
          • Patrick Denard, MD
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • The Hawkins Foundation
        • Principal Investigator:
          • Michael Kissenberth, MD
        • Contact:
          • Sam Pergiovanni
          • Phone Number: 888-666-2904
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Recruiting
        • The Campbell Clinic
        • Contact:
          • Margaret Knack
    • Virginia
      • Norfolk, Virginia, United States, 23462
        • Recruiting
        • Jordan Young Institute
        • Contact:
          • Amanda Firoved

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
  2. 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.
  3. Patient meets FDA cleared indications for reverse shoulder arthroplasty
  4. Patient is between 18-100 years old
  5. Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
  6. 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

Exclusion Criteria:

  1. Patient has a history of ipsilateral shoulder arthroplasty
  2. A history of shoulder septic arthritis
  3. A full thickness subscapularis tear
  4. An acute or malunited proximal humeral fracture
  5. Chronic locked dislocation
  6. Rheumatoid arthritis
  7. Tumors
  8. Axillary nerve damage
  9. Non-functioning deltoid muscle
  10. Glenoid vault deficiency precluding baseplate fixation
  11. Infection and neuropathic joints
  12. Known or suspected non-compliance, drug or alcohol abuse
  13. Patients incapable of judgement or under tutelage
  14. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc.
  15. The subject is related to investigator as family members, employees, or other dependent persons
  16. Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Reverse Shoulder Arthroplasty with subscapularis repair
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
Device: Repair of the subscapularis
The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.
No Intervention: Reverse Shoulder Arthroplasty without subscapularis repair
The subscapularis will not be repaired.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure.
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.
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
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.
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
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.
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
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.
Collected at the 2 year post-op timepoint, and is the primary outcome measure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ultrasound
Time Frame: Collected once at either the 6 month, 1 year or 2 year timepoint.
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".
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.
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.
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.
Provides a standardized way of recording the function of a shoulder before and after treatment.
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.
The standard measure for pain on a 0-10 scale, 10 being the worst.
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.
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.
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.
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.
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.
Asks patients to rate shoulder pain as a percentage of normal.
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.
A patient administered form that asks patients to evaluate their expectations of their scheduled Arthroplasty procedure.
Collected at the pre-op visit.
Return to Work Form
Time Frame: Collected at pre-op, 26 weeks and 1 year.
A patient administered form that asks patients to determine the effect that their shoulder has had on their employment.
Collected at pre-op, 26 weeks and 1 year.
Standard Late Postoperative Form
Time Frame: Collected at the 1 year and 2 year timepoints.
A patient administered form that asks patient to evaluate if their expectations were met regarding their Arthroplasty procedure.
Collected at the 1 year and 2 year timepoints.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arthrex, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIRR-00608-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings