Internal Rotation Contracture-shoulder, Patient Satisfaction, Shoulder Injuries
Conditions
Keywords
Reverse Total Shoulder Arthroplasty, Functional Internal Rotation, Conjoint Tendon
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.
Interventions
PROCEDUREConjoint 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.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
\- All patients undergoing primary reverse total shoulder arthroplasty (RTSA)
Exclusion criteria
* Revision RTSA * RTSA for acute proximal humerus fracture or fracture sequela
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Internal Shoulder Rotation | Functional Internal Shoulder Rotation will be measured at the 6 Month FU | . 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Total | Reverse Total Shoulder Arthroplasty |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 12 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 2 Participants |
| Age, Continuous | 69.97 years STANDARD_DEVIATION 5.241598895 | 70.71 years STANDARD_DEVIATION 6.049666234 | 71.46 years STANDARD_DEVIATION 6.881785696 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 9 Participants |
| Region of Enrollment United States | 8 participants | 17 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
Functional Internal Shoulder Rotation
. 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: Functional Internal Shoulder Rotation will be measured at the 6 Month FU
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | Lower Lumbar | 0 participants |
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | Upper Thoracic | 0 participants |
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | Ipsilateral buttock | 1 participants |
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | Thoracolumbar | 0 participants |
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | Mid-Lumbar | 1 participants |
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | T10 and Above | 0 participants |
| Reverse Total Shoulder Arthroplasty | Functional Internal Shoulder Rotation | Side | 1 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | T10 and Above | 0 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | Side | 1 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | Ipsilateral buttock | 2 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | Lower Lumbar | 0 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | Mid-Lumbar | 1 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | Upper Thoracic | 0 participants |
| Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection | Functional Internal Shoulder Rotation | Thoracolumbar | 0 participants |