Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

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

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-04-01

Brief Summary

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Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

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Detailed Description

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Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. Fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. Bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. Since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. The goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Conditions

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Rotator Cuff Arthropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Reverse total shoulder replacement

Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)

Group Type OTHER

Reverse total shoulder replacement

Intervention Type OTHER

Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement

Interventions

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Reverse total shoulder replacement

Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Minimum age of 18 years old
* Total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM) between 2007 and 2017 in UZ Leuven
* Primary indication for surgery is rotator cuff arthropathy
* Informed consent obtained

Exclusion Criteria

* Total shoulder replacement in post septic arthritis.
* Total shoulder replacement in post-instability arthritis.
* Revision total shoulder arthroplasty.
* Posttraumatic total shoulder arthroplasty (after failed index operation)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No