Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty

NCT04093804 | Unknown FDA Device

• 1 other identifier: TOH183
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.

Conditions

Rotator Cuff Tear Arthropathy; Massive Irreparable Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

• Active range of motion

  Shoulder elevation, abduction, external rotation in abduction, and internal rotation

  Change from baseline (pre-operative) to 2 years follow-up

• Passive range of motion

  Shoulder elevation and external rotation

  Change from baseline (pre-operative) to 2 years follow-up

Secondary Outcomes (2)

• American Shoulder and Elbow Surgeon (ASES) Shoulder Index

  Change from baseline (pre-operative) to 2 years follow-up

• Constant-Murley Shoulder Outcome score

  Change from baseline (pre-operative) to 2 years follow-up

Study Arms (2)

32mm Glenosphere

ACTIVE COMPARATOR

The control group will receive the standard 32mm glenosphere.

Device: Glenosphere size for Reverse Shoulder Arthroplasty

36mm Glenosphere

EXPERIMENTAL

The experimental group will receive a 36mm glenosphere.

Device: Glenosphere size for Reverse Shoulder Arthroplasty

Interventions

Glenosphere size for Reverse Shoulder Arthroplasty DEVICE

Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups.

32mm Glenosphere; 36mm Glenosphere

Eligibility Criteria

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

You may qualify if:

• Female sex
• Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty
• No history of prior shoulder arthroplasty
• Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C)
• Ability to speak, read and write English

You may not qualify if:

• Male sex
• Any impairment that would prevent answering the surveys
• No children or adolescents under the age of 18 years old
• No prisoners, pregnant women, or mentally disabled persons
• No Workers' Compensation cases

Sponsors & Collaborators

• Fondren Orthopedic Group L.L.P.: lead

Study Sites (1)

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Mollon B, Mahure SA, Roche CP, Zuckerman JD. Impact of glenosphere size on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 297 shoulders. J Shoulder Elbow Surg. 2016 May;25(5):763-71. doi: 10.1016/j.jse.2015.10.027. Epub 2016 Feb 4.

  PMID: 26853756 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Central Study Contacts

Mitzi S Laughlin, PhD

CONTACT

713-794-3408; Mitzi.Laughlin@fondren.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized trial consisting of female patients undergoing reverse shoulder arthroplasty for rotator cuff tear arthropathy or a massive irreparable rotator cuff tear. The experimental group will receive a 36mm glenosphere and the control group will receive the standard 32mm glenosphere. All other conditions of the surgical procedure will be identical as well as the clinical follow-up.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2024
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)