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

NCT02768597 | Completed Results DMC FDA Device

• 1 other identifier: 15-006839
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glenohumeral Joint Degeneration

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Oxford Shoulder Score (OSS) Questionnaire

  1 year

• American Shoulder and Elbow Surgeons (ASES) Questionnaire

  One year

• Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire

  One year

• Shoulder Pain

  One year

• Patient Satisfaction

  One year

Study Arms (4)

Large-Diameter Glenosphere +2 mm offset

ACTIVE COMPARATOR

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

Small-Diameter Glenosphere +2 mm offset

ACTIVE COMPARATOR

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

Large-Diameter Glenosphere +6 mm offset

ACTIVE COMPARATOR

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

Small-Diameter Glenosphere +6 mm offset

ACTIVE COMPARATOR

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

Interventions

ReUnion System with a Large-Diameter Glenosphere +2 mm offset DEVICE

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset

Large-Diameter Glenosphere +2 mm offset

ReUnion System with a Small-Diameter Glenosphere +2 mm offset DEVICE

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset

Small-Diameter Glenosphere +2 mm offset

ReUnion System with a Large-Diameter Glenosphere +6 mm offset DEVICE

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset

Large-Diameter Glenosphere +6 mm offset

ReUnion System with a Small-Diameter Glenosphere +6 mm offset DEVICE

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset

Small-Diameter Glenosphere +6 mm offset

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Stryker Nordic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Dr. Mark E. Morrey
• Organization: Mayo Clinic

morrey.mark@mayo.edu

507-284-2511

Study Officials

• Mark Morrey, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 11, 2016
• Study Start: April 1, 2016
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)