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OpenTrials
Completed

NCT Number: NCT06611059

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

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSG

Device

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

Primary outcomes

  1. 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

  2. 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).

  3. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: PSG

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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