Recruiting NCT03921944
Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT scan of the shoulders.
- Who it may be relevant to
- Registry conditions: Osteoarthritis of Shoulder. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test CT scan of the shoulders
studies of both operative and nonoperative shoulders
Primary outcome measures
- 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]
Secondary outcome measures (6)
- Tear in Rotator Cuff Muscles in both shoulders [Time frame: one year post surgery]
- Tear in Rotator Cuff Muscles in both shoulders [Time frame: two year post surgery]
- Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification [Time frame: one year post surgery]
- Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification [Time frame: two year post surgery]
- Fatty atrophy in Rotator Cuff Muscles in both shoulders [Time frame: one year post surgery]
- Fatty atrophy in Rotator Cuff Muscles in both shoulders [Time frame: two year post surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Penn State Hershey Medical Center — Hershey
Identifiers
NCT: NCT03921944 · STUDY00008095