Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term reverse shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.

Official Title
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Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Conditions
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Arthritis

Intervention / Treatment
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* Procedure: surgery
* Device: 0.8 mm diameter Tantalum marker beads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty. Exclusion Criteria: will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living >100 km outside of London).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pressfit humerus & non-lateralized glenoid<br>All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is -pressfit humerus & non-lateralized glenoid. | Procedure: surgery<br>* All patients will receive a Delta XTEND reverse shoulder implant<br>Device: 0.8 mm diameter Tantalum marker beads<br>* At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,<br>|
| Active Comparator: pressfit humerus & lateralized glenoid<br>All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is - pressfit humerus & lateralized glenoid. | Procedure: surgery<br>* All patients will receive a Delta XTEND reverse shoulder implant<br>Device: 0.8 mm diameter Tantalum marker beads<br>* At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,<br>|
| Active Comparator: cemented humerus & non-lateralized glenoid<br>All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component. Therefore, 4 randomization groups will be created and one of them is cemented humerus & non-lateralized glenoid | Procedure: surgery<br>* All patients will receive a Delta XTEND reverse shoulder implant<br>Device: 0.8 mm diameter Tantalum marker beads<br>* At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,<br>|
| Active Comparator: cemented humerus & lateralized glenoid.<br>All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is cemented humerus & lateralized glenoid. | Procedure: surgery<br>* All patients will receive a Delta XTEND reverse shoulder implant<br>Device: 0.8 mm diameter Tantalum marker beads<br>* At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced arthritis, shoulder