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Suture of the Tuberosities in Inverted Prostheses Implanted for Acute Fractures of the Proximal Humerus?.

It is Necessary to Suture the Tuberosities in Inverted Prostheses Implanted for Acute Fractures of the Proximal Humerus?. Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05462691
Enrollment
90
Registered
2022-07-18
Start date
2022-09-01
Completion date
2025-09-01
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fractures, Reverse Shoulder Prostheses, Tuberosities

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.

Interventions

PROCEDUREtuberosity suture

to suture or not suture the tuberosities in reverse shoulder arthroplasty because of a proximal humeral fracture

Sponsors

Hospital del Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

patients will be blinded to the assignment group. outcomes assessors will be blinded to the assignment group

Intervention model description

prospective randomized trial

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Simple Shoulder Test24 monthsPrimary 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.

Contacts

Primary ContactCarlos Torrens, MD
CTorrens@psmar.cat003493674100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026