UnknownNot Applicable

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

United States120 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Active range of motion

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

Passive range of motion

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

Trial details

NCT IDNCT04093804

SponsorFondren Orthopedic Group L.L.P.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-01

Contact for this trial

Mitzi S Laughlin, PhD

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

View on ClinicalTrials.gov More Rotator Cuff Tear Arthropathy trials