Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
Primary Purpose
Rotator Cuff Arthropathy
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Reverse total shoulder replacement
Sponsored by
About this trial
This is an interventional other trial for Rotator Cuff Arthropathy focused on measuring Reverse total shoulder arthroplasty
Eligibility Criteria
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)
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Reverse total shoulder replacement
Arm Description
Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical outcome
To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome
Constant-Murley score
To evaluate the functional state of the shoulder in patients with shoulder complaints
Short Form 36 Health Survey Questionnaire (SF-36)
To indicate the health status and pain scales
Net Promotor Score (NPS)
To evaluate patient satisfaction after surgery
Anchor Question Shoulder Score
To measure the change in general daily functioning and pain symptoms after shoulder surgery
Full Information
NCT ID
NCT04809077
First Posted
March 16, 2021
Last Updated
July 14, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04809077
Brief Title
Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
Official Title
Focus on the Humeral Component Following Reverse Shoulder Arthroplasty: Radiographic and Clinical Findings
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Arthropathy
Keywords
Reverse total shoulder arthroplasty
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reverse total shoulder replacement
Arm Type
Other
Arm Description
Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)
Intervention Type
Other
Intervention Name(s)
Reverse total shoulder replacement
Intervention Description
Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement
Primary Outcome Measure Information:
Title
Shoulder X-ray
Description
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.
Time Frame
up to 20 months
Secondary Outcome Measure Information:
Title
Clinical outcome
Description
To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome
Time Frame
up to 20 months
Title
Constant-Murley score
Description
To evaluate the functional state of the shoulder in patients with shoulder complaints
Time Frame
up to 20 months
Title
Short Form 36 Health Survey Questionnaire (SF-36)
Description
To indicate the health status and pain scales
Time Frame
up to 20 months
Title
Net Promotor Score (NPS)
Description
To evaluate patient satisfaction after surgery
Time Frame
one time visit
Title
Anchor Question Shoulder Score
Description
To measure the change in general daily functioning and pain symptoms after shoulder surgery
Time Frame
up to 20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Debeer
Phone
+32 16 34 08 72
Email
philippe.debeer@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Joris Beckers
Phone
+32 16 34 08 75
Email
joris.beckers@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
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