Focus on the Humeral Component Following Reverse Shoulder Arthroplasty (RSA)

Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Arthropathy
• Intervention / Treatment: Other: Reverse total shoulder replacement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reverse total shoulder replacement; Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)	Other: Reverse total shoulder replacement; Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder X-ray	To describe bony reaction at the bone-implant interface for the humeral component of a reverse shoulder arthroplasty. End-point radiographs will be compared to radiographs taken postoperatively in order to define stress shielding and/or bone resorption in the 5 humeral zones described by Nagels et al.	up to 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome	up to 20 months
Constant-Murley score	To evaluate the functional state of the shoulder in patients with shoulder complaints	up to 20 months
Short Form 36 Health Survey Questionnaire (SF-36)	To indicate the health status and pain scales	up to 20 months
Net Promotor Score (NPS)	To evaluate patient satisfaction after surgery	one time visit
Anchor Question Shoulder Score	To measure the change in general daily functioning and pain symptoms after shoulder surgery	up to 20 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Philippe Debeer, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Reverse total shoulder arthroplasty
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: S63831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No