Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty

A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System

The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.

Study Overview

• Status: Completed
• Conditions: Glenohumeral Joint Degeneration
• Intervention / Treatment: Device: ReUnion System with a Large-Diameter Glenosphere +2 mm offset; Device: ReUnion System with a Small-Diameter Glenosphere +2 mm offset; Device: ReUnion System with a Large-Diameter Glenosphere +6 mm offset; Device: ReUnion System with a Small-Diameter Glenosphere +6 mm offset

Detailed Description

A total of 220 shoulders will be included in the study (55 shoulders in each of the four groups). Each shoulder will be assessed preoperatively, at 3 weeks, 3 months, one year, two years and five years. The primary end-point will be range of motion at one year. Additional end-points will include dislocation, stress fractures of the acromion, metal ion levels in peripheral blood, neurovascular complications, radiographic notching, implant mechanical failure and revision surgery.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damian Paulson; Phone Number: 507-284-1175; Email: Paulson.Damian@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects willing to sign the informed consent
• Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
• Subjects requiring a primary reverse total shoulder arthroplasty
• Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss

Exclusion Criteria:

• Inability to comply with follow-up requirements
• Subjects with inflammatory arthritis
• Subjects with proximal humerus fractures
• Subjects with sequels of trauma
• Subjects that are immunologically compromised
• Subjects with an active or suspected latent infection in or about the shoulder
• Need to add a tendon transfer
• Need for structural humeral bone graft
• Pregnant subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Large-Diameter Glenosphere +2 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset	Device: ReUnion System with a Large-Diameter Glenosphere +2 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
Active Comparator: Small-Diameter Glenosphere +2 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset	Device: ReUnion System with a Small-Diameter Glenosphere +2 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
Active Comparator: Large-Diameter Glenosphere +6 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset	Device: ReUnion System with a Large-Diameter Glenosphere +6 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
Active Comparator: Small-Diameter Glenosphere +6 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset	Device: ReUnion System with a Small-Diameter Glenosphere +6 mm offset; Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Forward Elevation of the Shoulder	Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees.	One year
Active External Rotation of the Shoulder	Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees.	One year
Shoulder Abduction Strength	Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.	one year
Shoulder External Rotation Strength	Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.	One year
Shoulder Internal Rotation Strength	Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score (OSS) Questionnaire	The Oxford Shoulder Score (OSS) is a patient reported questionnaire that includes 12 descriptors of pain and disability for shoulder ailments and related quality of daily activities. Each descriptor rating ranges from 0 to 4, with 4 representing the best (no pain, no difficulty with activity) and 0 is the worst (unbearable pain, extreme difficulty with activity). The score is calculated from the summation of all 12 descriptors, for a total range of 0 to 48, where a higher score reflects the best outcome (less pain and difficulty with activity) and a lower score reflects a worse outcome (more pain and difficulty with activity).	1 year
American Shoulder and Elbow Surgeons (ASES) Questionnaire	A self-assessment that measures pain and ability to perform daily activities.The questionnaire is divided into 2 components, a single pain question and 10 questions on function of daily living.The total score is weighted 50% for pain and 50% for function. Pain is ranked from 0-10, where 0 is no pain and 10 is unbearable pain.The total pain score is calculated by subtracting the result of this question from 10 and multiplying by 5.The function score is calculated from the sum of 10 questions on daily living.The 10 questions are scored from 0-3, where 0=unable to perform daily activity and 3=no difficulty with daily activity.The individual function scores are summed for a maximum functional score of 30.This functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points.The pain and function scores are then added together to obtain the final score out of 100.The final score ranges from 0 to 100, where higher scores correlate to better outcomes.	One year
Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire	The Quick DASH (disabilities of the arm, shoulder and hand) questionnaire is an 11 item self-reported participant questionnaire that measures physical function and symptoms in individuals experiencing musculoskeletal disorders of the upper limb. Each item is scored 1-5 where 1 reflects no pain or difficulty with activities and 5 reflects extreme pain or difficulty with activities. All individual scores are then summed and averaged to produce a score out of five. The score is then transformed to a score out of 100 by subtracting one and multiplying by 25. The final score ranges from 0 to 100, where a higher resulting score reflects more pain and greater disability while a lower score reflects less pain and disability.	One year
Shoulder Pain	Shoulder pain values reported by participants will be assessed using the 10cm Visual Analogue Scale (VAS). The VAS line will be 10 cm long with two endpoints representing 0 (no pain) and 10 (worst possible pain). Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of centimeters will be reported as the pain score.	One year
Patient Satisfaction	Patient satisfaction with the outcome of the surgery measured by on a scale from 1-10, where 1 is not at all satisfied and 10 is very satisfied.	One year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Stryker Nordic
• Investigators: Principal Investigator: Mark Morrey, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimated): May 11, 2016

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 15-006839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No