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Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

Primary Purpose

Shoulder Injuries, Patient Satisfaction, Internal Rotation Contracture-shoulder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conjoint Tendon Resection
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries focused on measuring Reverse Total Shoulder Arthroplasty, Functional Internal Rotation, Conjoint Tendon

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria - All patients undergoing primary reverse total shoulder arthroplasty (RTSA) Exclusion criteria Revision RTSA RTSA for acute proximal humerus fracture or fracture sequela

Sites / Locations

  • Missouri Orthopaedic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Reverse Total Shoulder Arthroplasty

Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection

Arm Description

For RTSA using a deltopectoral approach, the Perform glenoid and humeral components of Tornier Stryker Reverse Shoulder system will be used for all cases. The sizes and offsets of the components will be chosen based on each patient's local anatomy which will vary among patients. The subscapularis tendon will be repaired using three transosseous nonabsorbable sutures whenever there is a reparable subscapularis tendon. After definitive implantation of the prosthesis is completed, in the 'no interventional' group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling.

RTSA in the experimental group will be identical, except for that after definitive implantation of the prosthesis is completed, in the 'experimental' group, the conjoint tendon will be released completely via a transverse incision made at a level 2 cm distal to the coracoid process for the patients assigned the conjoint resection group. Electrocautery will be used for the resection, and the underlying muscular portion of the conjoint tendon will be preserved. As mentioned above, the control group will not receive this conjoint tendon resection. Similarly, in the experimental group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling.

Outcomes

Primary Outcome Measures

Change in Functional Internal Shoulder Rotation Over Time Points
. Functional internal rotation will be measured based on the highest anatomical level that the patient's thumb can reach: Side Ipsilateral buttock Lower lumbar Mid-lumbar Upper lumbar Thoracolumbar junction T10 and above

Secondary Outcome Measures

Change in Visual Analog Scale (VAS) Pain Score Over Time Points
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Change in American Shoulder and Elbow (ASES) Score Over Time Points
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes (Leggin, 2006).
Change in Single Assessment Numeric Evaluation (SANE) Score Over Time Points
The SANE is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures.
Change in Patient Reported Outcome Information System (PROMIS) Score Over Time Points
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population).
Change in Veterans Rand 12 Health (VR-12) Score Over Time Points
The Veterans RAND 12-Item Health Survey (VR-12) is a self-reported global health measure used to assess a patient's overall perspective of their health

Full Information

First Posted
February 12, 2023
Last Updated
April 10, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05753904
Brief Title
Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty
Official Title
The Impact of Conjoint Tendon Resection on Functional Internal Rotation of the Shoulder Following Reverse Shoulder Arthroplasty: A Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Reverse total shoulder arthroplasty (RTSA) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears. However, functional internal rotation (i.e., functional movements of the hand behind the body) is often unsatisfactorily restored and/or lost after RTSA. This study aims to compare the standard surgical approach for RTSA to RTSA with conjoint tendon resection with the targeted metric being postoperative functional internal rotation.
Detailed Description
This study will be a prospective, randomized-controlled clinical trial comparing standard of care RTSA to RTSA with conjoint tendon resection in 64 patients undergoing RTSA by a single surgeon. Participants and assessors will not be blinded to intervention. The primary outcome is postoperative functional internal rotation. Secondary outcome measures include VAS, ASES, SANE, PROMIS, and VR-12 scores, as well as forward elevation and external rotation at the side, and complications at any time point. Our null hypothesis is that patients who undergo conjoint tendon resection during RTSA will have significantly increased functional internal rotation and clinically significant improved above-mentioned scores compared to non-resected tendon patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Patient Satisfaction, Internal Rotation Contracture-shoulder
Keywords
Reverse Total Shoulder Arthroplasty, Functional Internal Rotation, Conjoint Tendon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a prospective, randomized-controlled clinical trial comparing standard of care RTSA to RTSA with conjoint tendon resection in 64 patients undergoing RTSA by a single surgeon.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and assessors will not be blinded to intervention. The primary outcome is postoperative functional internal rotation. Secondary outcome measures include VAS, ASES, SANE, PROMIS, and VR-12 scores, as well as forward elevation and external rotation at the side, and complications at any time point. Our null hypothesis is that patients who undergo conjoint tendon resection during RTSA will have significantly increased functional internal rotation and clinically significant improved above-mentioned scores compared to non-resected tendon patients.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reverse Total Shoulder Arthroplasty
Arm Type
No Intervention
Arm Description
For RTSA using a deltopectoral approach, the Perform glenoid and humeral components of Tornier Stryker Reverse Shoulder system will be used for all cases. The sizes and offsets of the components will be chosen based on each patient's local anatomy which will vary among patients. The subscapularis tendon will be repaired using three transosseous nonabsorbable sutures whenever there is a reparable subscapularis tendon. After definitive implantation of the prosthesis is completed, in the 'no interventional' group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling.
Arm Title
Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection
Arm Type
Experimental
Arm Description
RTSA in the experimental group will be identical, except for that after definitive implantation of the prosthesis is completed, in the 'experimental' group, the conjoint tendon will be released completely via a transverse incision made at a level 2 cm distal to the coracoid process for the patients assigned the conjoint resection group. Electrocautery will be used for the resection, and the underlying muscular portion of the conjoint tendon will be preserved. As mentioned above, the control group will not receive this conjoint tendon resection. Similarly, in the experimental group, the wound will be closed in layers, and the shoulder will be immobilized in an abduction sling.
Intervention Type
Procedure
Intervention Name(s)
Conjoint Tendon Resection
Intervention Description
For conjoint tendon resection in the experimental group, the conjoint tendon will be released completely via a transverse incision made at a level 2 cm distal to the coracoid process for the patients assigned the conjoint resection group. Electrocautery will be used for the resection, and the underlying muscular portion of the conjoint tendon will be preserved.
Primary Outcome Measure Information:
Title
Change in Functional Internal Shoulder Rotation Over Time Points
Description
. Functional internal rotation will be measured based on the highest anatomical level that the patient's thumb can reach: Side Ipsilateral buttock Lower lumbar Mid-lumbar Upper lumbar Thoracolumbar junction T10 and above
Time Frame
All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.
Secondary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Pain Score Over Time Points
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.
Title
Change in American Shoulder and Elbow (ASES) Score Over Time Points
Description
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes (Leggin, 2006).
Time Frame
All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.
Title
Change in Single Assessment Numeric Evaluation (SANE) Score Over Time Points
Description
The SANE is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures.
Time Frame
All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.
Title
Change in Patient Reported Outcome Information System (PROMIS) Score Over Time Points
Description
PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population).
Time Frame
All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.
Title
Change in Veterans Rand 12 Health (VR-12) Score Over Time Points
Description
The Veterans RAND 12-Item Health Survey (VR-12) is a self-reported global health measure used to assess a patient's overall perspective of their health
Time Frame
All participants were be surveilled per standard of care at our hospital for the targeted patient group. Patients will return for follow-up at two weeks, six weeks, three months, six months, one year, and two years.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria - All patients undergoing primary reverse total shoulder arthroplasty (RTSA) Exclusion criteria Revision RTSA RTSA for acute proximal humerus fracture or fracture sequela
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Gusho, MD
Phone
2622417944
Email
umhsorthoenroll@umsystem.edu
First Name & Middle Initial & Last Name or Official Title & Degree
H. Mike Kim, MD
Phone
2622417944
Email
hmkim@umsystem.edu
Facility Information:
Facility Name
Missouri Orthopaedic Institute
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Mike Kim, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data collection for individual participant data will primarily be electronically based and not available to members outside of the research team. A breach of confidentiality and/or privacy is a risk of this study. To prevent this, all collected data will be stored electronically in password-protected files to protect patient identity and information. All information will be collected and reviewed by the research team only. Data will be maintained on a password-protected computer that will be accessible only to the study team. No patient identifiers will be maintained in the database. Every attempt will be made to minimize missing data. Multiple contact details will be taken at recruitment, and a system of reminders plus phone contact if applicable will be made to ensure patients make follow-up appointments.

Learn more about this trial

Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty

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