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

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093804
• Other study ID #: TOH183
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2019
• Source: Fondren Orthopedic Group L.L.P.
• Contact: Mitzi S Laughlin, PhD
• Phone: 713-794-3408
• Email: Mitzi.Laughlin[@]fondren.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Massive Irreparable Rotator Cuff Tear
• Rotator Cuff Injuries
• Rotator Cuff Tear Arthropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Fondren Orthopedic Group, L.L.P.	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Fondren Orthopedic Group L.L.P.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active range of motion	Shoulder elevation, abduction, external rotation in abduction, and internal rotation	Change from baseline (pre-operative) to 2 years follow-up
Primary	Passive range of motion	Shoulder elevation and external rotation	Change from baseline (pre-operative) to 2 years follow-up
Secondary	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
Secondary	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