Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty

Lawson Health Research Institute

Status and phase: Unknown; Phase 3

Conditions: Arthritis

Treatments: Procedure: surgery; Device: 0.8 mm diameter Tantalum marker beads

Study type: Interventional

Funder types: Other

Identifiers

NCT02305966

7519

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 4 patient groups

pressfit humerus & non-lateralized glenoid

Active Comparator group

Description:

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.

Treatment:

Device: 0.8 mm diameter Tantalum marker beads

Procedure: surgery

pressfit humerus & lateralized glenoid

Active Comparator group

Description:

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.

Treatment:

Device: 0.8 mm diameter Tantalum marker beads

Procedure: surgery

cemented humerus & non-lateralized glenoid

Active Comparator group

Description:

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

Treatment:

Device: 0.8 mm diameter Tantalum marker beads

Procedure: surgery

cemented humerus & lateralized glenoid.

Active Comparator group

Description:

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.

Treatment:

Device: 0.8 mm diameter Tantalum marker beads

Procedure: surgery