Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty (PSG)

November 4, 2024 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

This is a two steps observational study

In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described.

Once the accuracy of the guide is acceptable, we will implant the glenosphere of future patients using the PSG guide following the same engineering design process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reverse shoulder arthroplasty is a treatment for both non-synthesizable fractures and arthropathy degenerative. This implant is based on two main components: glenosphere and stem. The stem in turn is integrated in its upper part by a polyethylene that reduces the friction torque between the glenosphere and the stem.

Correct positioning of the glenosphere is critical for functionality and survival of the implant. Malpositioning of glenosphere can be related to:

In recent years, given the

  • The scapula is a flat bone, without any reference axis;
  • Surgical approaches expose only the glenoid cavity, with few bone landmarks;
  • The humerus and deltoid make access to the glenoid difficult;
  • The morphology of the scapula is very variable.

Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid. In glenoids with only a slight deformity, PSGs improve the accuracy of the guide entry point (<1 mm error, compared to > 4 mm under visual control) and orientation (< 3◦ error compared to > 7◦). In glenoids with more significant deformities, planning also showed superiority.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inclusion Criteria:

  • Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
  • Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

Description

Inclusion Criteria:

  • Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
  • Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

Exclusion Criteria:

  • Previous surgeries on the proximal humerus or glenoid
  • No desire to participate in the study
  • Lack of ability to accept the study (tutored patients)
  • Open fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
in-hospital designed patient specific guide
Device: PSG
Two replicas of each scapula are made. The scapulae are drilled with a commercial guide and with an in-house guide separately
Other Names:
  • Patient Specific Guides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in glenoid center
Time Frame: months
Difference in glenoid center (mm): distance between the points of entry on the surface of the scapula, the planned center versus the finally drawn
months
Glenoid version deviation (α)
Time Frame: months
Glenoid version deviation (α): defined as the angle between the real trajectory of the drilling and the scapular anatomical plane, projected about the axis of neutral inclination (defined as that which goes from the center of the glenoid to the trigonum spinae).
months
Glenoid inclination deviation (β)
Time Frame: months
Glenoid inclination deviation (β): defined as the angle between the actual milling path and the plane of the neutral tilt axis, projected on the SP axis
months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: A. Millan, Orthopedic and Trauma Dept. / Trauma Unit
  • Study Director: A. Toro, Orthopedic and Trauma Dept. / Trauma Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

January 23, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-PSG-2023-107 (Registry Identifier: Clinical Research Ethics Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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