Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty

NCT ID: NCT06316050

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2023-06-28

Brief Summary

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Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.

Detailed Description

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Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.

Conditions

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Rotator Cuff Tears Rotator Cuff Tear Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Open randomized controlled clinical trial.

Study Groups

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humeral retroversion 0º

will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital

Group Type ACTIVE_COMPARATOR

humeral retroversion

Intervention Type PROCEDURE

REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion

humeral retroversion 30º

will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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humeral retroversion

REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Good functionality of the deltoid muscle.
* Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
* Accept informed consent

Exclusion Criteria

* \- Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
* Fracture of shoulder in the upper extremity to intervene.
* Central neurological diseases
* Advanced cognitive impairment
* Brachial plexus injuries
* Local or systemic infection.
* Oncological disease
* Treatment with immunosuppressants.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Josep Maria Mora Guix

Chief of Shoulder Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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JM MORA

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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cst

Identifier Type: -

Identifier Source: org_study_id

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