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Investigator No Longer at Institution
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reverse Total Shoulder Arthroplasty | No Intervention | 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. | |
| Reverse Total Shoulder Arthroplasty with Conjoint Tendon Resection | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conjoint Tendon Resection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Internal Shoulder Rotation | . Functional internal rotation will be measured based on the highest anatomical level that the patient's thumb can reach:
| Functional Internal Shoulder Rotation will be measured at the 6 Month FU |
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Inclusion criteria
- All patients undergoing primary reverse total shoulder arthroplasty (RTSA)
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Orthopaedic Institute | Columbia | Missouri | 65201 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reverse Total Shoulder Arthroplasty | 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. |
| FG001 | Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | 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. Conjoint Tendon Resection: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reverse Total Shoulder Arthroplasty | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Internal Shoulder Rotation | . Functional internal rotation will be measured based on the highest anatomical level that the patient's thumb can reach:
| Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. | Posted | Number | participants | Functional Internal Shoulder Rotation will be measured at the 6 Month FU |
|
6 months
No adverse events among participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reverse Total Shoulder Arthroplasty | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicki Jones | University of Missouri | 573-882-7583 | jonesvicki@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2022 | Mar 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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.
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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.
|
| BG001 | Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | 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. Conjoint Tendon Resection: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | 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. Conjoint Tendon Resection: 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. |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | 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. Conjoint Tendon Resection: 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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