Clinical Trial Finder

Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty

Study Purpose

The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.

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 45 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - age >45yrs.
  • - primary diagnosis of osteoarthritis of the shoulder.
  • - total shoulder replacement performed by Dr.
Armstrong.
  • - administered a local anesthetic mixture and not regional anesthesia.
  • - all genders.
  • - Fluent in written and spoken English.
  • - Patients capable of giving informed consent.

Exclusion Criteria:

  • - Known contraindications to CT/EMG.
  • - Inability to provide informed consent.
  • - History of recent trauma to the shoulder.
  • - Atypical shoulder pain.
  • - Other suspected shoulder pathology (i.e. tumor, infection) - Pregnancy.
- Bilateral total shoulder arthroplasty

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.

 NCT03921944
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.

 Milton S. Hershey Medical Center
Principal Investigator

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

 April D Armstrong, MD
Principal Investigator Affiliation Milton S. Hershey Medical Center
Agency Class

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

 Other
Overall Status Recruiting
Countries United States
Conditions

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

 Osteoarthritis of Shoulder
Arms & Interventions

Arms

Other: total shoulder replacement surgery

Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery

Interventions

Diagnostic Test: - CT scan of the shoulders

studies of both operative and nonoperative shoulders

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.

Penn State Hershey Medical Center, Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

Site Contact

Padmavathi Ponnuru, Ph.D.

[email protected]

717-531-0003 #284476

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