Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Phase 3

• Conditions: Arthritis
• Interventions: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads

• Registration Number: NCT02305966
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24
• Study Start: 2017-08-01
• Primary Completion: 2018-12
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pressfit humerus & lateralized glenoid	surgery	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.
pressfit humerus & non-lateralized glenoid	surgery	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.
pressfit humerus & non-lateralized glenoid	0.8 mm diameter Tantalum marker beads	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.
cemented humerus & non-lateralized glenoid	surgery	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
pressfit humerus & lateralized glenoid	0.8 mm diameter Tantalum marker beads	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.
cemented humerus & non-lateralized glenoid	0.8 mm diameter Tantalum marker beads	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
cemented humerus & lateralized glenoid.	0.8 mm diameter Tantalum marker beads	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.
cemented humerus & lateralized glenoid.	surgery	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.

Primary Outcome Measures

Name	Time	Method
migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis	24 months

Secondary Outcome Measures

Name	Time	Method
difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis	24 months