Trial Outcomes & Findings for Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty (NCT NCT05753904)
NCT ID: NCT05753904
Last Updated: 2025-10-30
Results Overview
. 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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Functional Internal Shoulder Rotation will be measured at the 6 Month FU
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Reverse Total Shoulder Arthroplasty
n=9 Participants
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
n=8 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
71.46 years
STANDARD_DEVIATION 6.881785696 • n=5 Participants
|
69.97 years
STANDARD_DEVIATION 5.241598895 • n=7 Participants
|
70.71 years
STANDARD_DEVIATION 6.049666234 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Functional Internal Shoulder Rotation will be measured at the 6 Month FUPopulation: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team.
. 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
Outcome measures
| Measure |
Reverse Total Shoulder Arthroplasty
n=3 Participants
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
n=4 Participants
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.
|
|---|---|---|
|
Functional Internal Shoulder Rotation
Thoracolumbar
|
0 participants
|
0 participants
|
|
Functional Internal Shoulder Rotation
Side
|
1 participants
|
1 participants
|
|
Functional Internal Shoulder Rotation
Ipsilateral buttock
|
1 participants
|
2 participants
|
|
Functional Internal Shoulder Rotation
Lower Lumbar
|
0 participants
|
0 participants
|
|
Functional Internal Shoulder Rotation
Mid-Lumbar
|
1 participants
|
1 participants
|
|
Functional Internal Shoulder Rotation
Upper Thoracic
|
0 participants
|
0 participants
|
|
Functional Internal Shoulder Rotation
T10 and Above
|
0 participants
|
0 participants
|
Adverse Events
Reverse Total Shoulder Arthroplasty
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reverse Total Shoulder Arthroplasty With Conjoint Tendon Resection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place