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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear Arthropathy; Massive Irreparable Rotator Cuff Tear
• Intervention / Treatment: Device: Glenosphere size for Reverse Shoulder Arthroplasty

Detailed Description

A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitzi S Laughlin, PhD; Phone Number: 713-794-3408; Email: Mitzi.Laughlin@fondren.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Fondren Orthopedic Group, L.L.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 32mm Glenosphere; The control group will receive the standard 32mm glenosphere.	Device: Glenosphere size for Reverse Shoulder Arthroplasty; 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.
Experimental: 36mm Glenosphere; The experimental group will receive a 36mm glenosphere.	Device: Glenosphere size for Reverse Shoulder Arthroplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeon (ASES) Shoulder Index	Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)	Change from baseline (pre-operative) to 2 years follow-up
Constant-Murley Shoulder Outcome score	Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)	Change from baseline (pre-operative) to 2 years follow-up

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Rupture; Shoulder Injuries; Tendon Injuries; Crystal Arthropathies; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy
• Other Study ID Numbers: TOH183

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