Recruiting

Observational Study

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT03921944

Conditions

Osteoarthritis of Shoulder

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

CT scan of the shoulders

Study Details

Brief summary:

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.

Conditions

Osteoarthritis of Shoulder

Study ID

NCT03921944

Start date

May 2, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

CT scan of the shoulders

studies of both operative and nonoperative shoulders

Primary outcome measure

  • Active Nerve Denervation [ Time Frame: one year post surgery ]
  • Active Nerve Denervation [ Time Frame: two year post surgery ]
  • Neuropathic Changes_amplitude [ Time Frame: one year post surgery ]
  • Neuropathic Changes_amplitude [ Time Frame: two year post surgery ]
  • Neuropathic Changes_recruitment pattern [ Time Frame: one year post surgery ]
  • Neuropathic Changes_recruitment pattern [ Time Frame: two year post surgery ]
  • Neuropathic Changes_duration [ Time Frame: one year post surgery ]
  • Neuropathic Changes_duration [ Time Frame: two year post surgery ]
  • Total number of Muscles affected with active denervation [ Time Frame: one year post surgery ]
  • Total number of Muscles affected with active denervation [ Time Frame: two year post surgery ]
  • Total number of muscles affected with neuropathic changes [ Time Frame: one year post surgery ]
  • Total number of muscles affected with neuropathic changes [ Time Frame: two year post surgery ]

Central Contacts and Locations

Central contacts

Padmavathi Ponnuru, PhD

717-531-0003pponnuru@pennstatehealth.psu.edu

Locations

Penn State Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Padmavathi Ponnuru, Ph.D.

717-531-0003pponnuru@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • shoulder surgery
  • arthritis
  • rotator cuff

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2026-08-13.