Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

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.

Study Overview

• Status: Unknown
• Conditions: Arthritis
• Intervention / Treatment: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kate Kelly, M.Sc,MPH/Gero; Phone Number: 64640 519-646-6100; Email: Kate.Kelly@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pressfit humerus & non-lateralized glenoid; 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; All patients will receive a Delta XTEND reverse shoulder implant; Device: 0.8 mm diameter Tantalum marker beads; At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,
Active Comparator: pressfit humerus & lateralized glenoid; 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; All patients will receive a Delta XTEND reverse shoulder implant; Device: 0.8 mm diameter Tantalum marker beads; At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,
Active Comparator: cemented humerus & non-lateralized glenoid; 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; All patients will receive a Delta XTEND reverse shoulder implant; Device: 0.8 mm diameter Tantalum marker beads; At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,
Active Comparator: cemented humerus & lateralized glenoid.; 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; All patients will receive a Delta XTEND reverse shoulder implant; Device: 0.8 mm diameter Tantalum marker beads; At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: shoulder; advanced arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 7519

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No