Clinical trial NCT05462691: "Suture of the Tuberosities in Inverted Prostheses" Implanted for Acute Fractures of the Proximal Humerus?.
Official title: "It is Necessary to Suture the Tuberosities in Inverted Prostheses Implanted for Acute Fractures of the Proximal Humerus?. Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized trial
Primary purpose: TREATMENT

Brief summary: Complex fractures of the proximal humerus in elderly patients constitute a growing problem. Osteoporosis linked to these fractures prevents osteosynthesis correctly, so that if the offset between the fragments is large, it is necessary to implant a prosthesis. Inverted prostheses, normally used for the treatment of osteoarthritis with absence of the rotator cuff, have become the treatment of choice in these fractures obtaining very favorable results. Traditionally, once the prosthesis is implanted, they are sutured the tuberosities with the rotator cuff tendons to the prosthesis. This gesture is supposed to will improve patient function. However, this prosthesis was originally designed for use in patients without a rotator cuff, so the need for this suture, which lengthens surgical time and requires an increase in the number of sutures, which can potentially increase the risk of infection. With the results of this study, it would be possible to reduce the surgical time, the number of inert materials implanted, and potentially the risk of infection.

Detailed description: Complex fractures of the proximal humerus in elderly patients constitute a growing problem. Osteoporosis linked to these fractures prevents osteosynthesis correctly, so that if the offset between the fragments is large, it is necessary to implant a prosthesis. Inverted prostheses, normally used for the treatment of osteoarthritis with absence of the rotator cuff, have become the treatment of choice in these fractures obtaining very favorable results. Traditionally, once the prosthesis is implanted, they are sutured the tuberosities with the rotator cuff tendons to the prosthesis. This gesture is supposed to will improve patient function. However, this prosthesis was originally designed for use in patients without a rotator cuff, so the need for this suture, which lengthens surgical time and requires an increase in the number of sutures, which can potentially increase the risk of infection. With the results of this study, it would be possible to reduce the surgical time, the number of inert materials implanted, and potentially the risk of infection.

Primary objective:

To determine if there are differences in the perception of quality of life measured by through the Simple Shoulder Test scale, among the patients in whom sutured the tuberosities and patients who have had the tuberosities excised tuberosities.

Secondary objectives:

To determine if there are differences between the patients in whom suturing has been the tuberosities and patients who have had their tuberosities excised about:

* SPADI quality of life test.
* Constant functional test.
* number of prosthetic dislocations
* Percentage of scapular notch development measured according to the Sirveaux scale.
* Number of dislocations.
* number of infections.
* number of revision surgeries.

Eligibility criteria: Inclusion Criteria:

* patients \> 65 yrs. and \< 85 yrs.
* Acute fracture of the proximal humerus.
* implantation of inverted shoulder prosthesis.

Exclusion Criteria:

* acute fractures of more than 3 weeks of evolution
* Associated fractures.
* senile dementia and/or cognitive alterations that prevent compliance protocols

Primary outcomes:
measure: Simple Shoulder Test
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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