Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
- Conditions
- Rotator Cuff Arthropathy
- Interventions
- Other: Reverse total shoulder replacement
- Registration Number
- NCT04809077
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Reverse total shoulder replacement Reverse total shoulder replacement Patients who underwent a total shoulder replacement using a reverse type implant (Delta Xtend or Zimmer TM)
- Primary Outcome Measures
Name Time Method Shoulder X-ray up to 20 months 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
Name Time Method Constant-Murley score up to 20 months To evaluate the functional state of the shoulder in patients with shoulder complaints
Anchor Question Shoulder Score up to 20 months To measure the change in general daily functioning and pain symptoms after shoulder surgery
Net Promotor Score (NPS) one time visit To evaluate patient satisfaction after surgery
Clinical outcome up to 20 months To relate bony changes at the bone-implant interface of the humeral component of a reverse total shoulder arthroplasty to clinical outcome
Short Form 36 Health Survey Questionnaire (SF-36) up to 20 months To indicate the health status and pain scales
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium