Focus on the Humeral Component Following Reverse Shoulder Arthroplasty

Rotator Cuff Arthropathy Clinical Trial

— RSA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04809077
• Other study ID #: S63831
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Joint Diseases
• Rotator Cuff Arthropathy

Intervention

Other:
• Reverse total shoulder replacement
Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Constant-Murley score	To evaluate the functional state of the shoulder in patients with shoulder complaints	up to 20 months
Secondary	Short Form 36 Health Survey Questionnaire (SF-36)	To indicate the health status and pain scales	up to 20 months
Secondary	Net Promotor Score (NPS)	To evaluate patient satisfaction after surgery	one time visit
Secondary	Anchor Question Shoulder Score	To measure the change in general daily functioning and pain symptoms after shoulder surgery	up to 20 months