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Influenze of Approach in Reversed Shoulder Prosthesis

Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04405947
Enrollment
100
Registered
2020-05-28
Start date
2016-01-13
Completion date
2020-10-29
Last updated
2021-03-30

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

Conditions

Outcomes Assessments, Patients, Rotator Cuff Arthropathy

Keywords

reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach

Brief summary

To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.

Detailed description

Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.

Interventions

implantation of a reversed shoulder prostheses through two different surgical approaches

Sponsors

Hospital del Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded

Intervention model description

prospective randomized study

Eligibility

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

Inclusion criteria

* Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis * Acute fractures \<2 weeks of evolution in patients candidates for inverted prostheses * No previous surgeries of the affected shoulder * Acceptance by the patient to participate in the study

Exclusion criteria

* Fractures\> 2 weeks of evolution * Previous surgeries on the affected shoulder * Not signing the informed consent * Cognitive impairment * Institutionalization of the patient

Design outcomes

Primary

MeasureTime frameDescription
positioning of the metaglene of the reverse shoulder prostheses2 yearsto determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.

Secondary

MeasureTime frameDescription
functional outcome2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.determine the functional outcome as measured with the Constant Score at 2-years follow-up
scapular notch2 yearsdetermine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.

Outcome results

None listed

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