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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04093804
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Fondren Orthopedic Group L.L.P.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rotator Cuff Tear Arthropathy, Massive Irreparable Rotator Cuff Tear
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 32mm Glenosphere

The control group will receive the standard 32mm glenosphere.

Experimental: 36mm Glenosphere

The experimental group will receive a 36mm glenosphere.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fondren Orthopedic Group, L.L.P., Houston, Texas

Status

Address

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030

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