Clinical trial NCT03921944: Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
Official title: Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of Shoulder
Keywords: shoulder surgery
arthritis
rotator cuff
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Active Nerve Denervation
timeFrame: one year post surgery
measure: Active Nerve Denervation
timeFrame: two year post surgery
measure: Neuropathic Changes_amplitude
timeFrame: one year post surgery
measure: Neuropathic Changes_amplitude
timeFrame: two year post surgery
measure: Neuropathic Changes_recruitment pattern
timeFrame: one year post surgery
measure: Neuropathic Changes_recruitment pattern
timeFrame: two year post surgery
measure: Neuropathic Changes_duration
timeFrame: one year post surgery
measure: Neuropathic Changes_duration
timeFrame: two year post surgery
measure: Total number of Muscles affected with active denervation
timeFrame: one year post surgery
measure: Total number of Muscles affected with active denervation
timeFrame: two year post surgery
measure: Total number of muscles affected with neuropathic changes
timeFrame: one year post surgery
measure: Total number of muscles affected with neuropathic changes
timeFrame: two year post surgery
Secondary outcomes:
measure: Tear in Rotator Cuff Muscles in both shoulders
timeFrame: one year post surgery
measure: Tear in Rotator Cuff Muscles in both shoulders
timeFrame: two year post surgery
measure: Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
timeFrame: one year post surgery
measure: Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification
timeFrame: two year post surgery
measure: Fatty atrophy in Rotator Cuff Muscles in both shoulders
timeFrame: one year post surgery
measure: Fatty atrophy in Rotator Cuff Muscles in both shoulders
timeFrame: two year post surgery
Other outcomes:
measure: Forward Elevation for Active Range of Motion
timeFrame: one year post surgery
measure: Forward Elevation for Active Range of Motion
timeFrame: two year post surgery
measure: Forward Elevation for Passive Range of Motion
timeFrame: one year post surgery
measure: Forward Elevation for Passive Range of Motion
timeFrame: two year post surgery
measure: External Rotation (side) for Passive Range of Motion
timeFrame: one year post surgery
measure: External Rotation (side) for Passive Range of Motion
timeFrame: two year post surgery
measure: External Rotation (side) for Active Range of Motion
timeFrame: one year post surgery
measure: External Rotation (side) for Active Range of Motion
timeFrame: two year post surgery
measure: Range of Motion in both shoulders_ Internal Rotation
timeFrame: one year post surgery
measure: Range of Motion in both shoulders_ Internal Rotation
timeFrame: two year post surgery
measure: Measurement of strength in both shoulders_Jobe's test
timeFrame: one year post surgery
measure: Measurement of strength in both shoulders_Jobe's test
timeFrame: two year post surgery
measure: Measurement of strength in both shoulders_External Rotation (at side)
timeFrame: one year post surgery
measure: Measurement of strength in both shoulders_External Rotation (at side)
timeFrame: two year post surgery
measure: Measurement of strength in both shoulders_Belly Press
timeFrame: one year post surgery
measure: Measurement of strength in both shoulders_Belly Press
timeFrame: two year post surgery
measure: Measurement of strength in both shoulders_Lift off Test
timeFrame: one year post surgery
measure: Measurement of strength in both shoulders_Lift off Test
timeFrame: two year post surgery
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: April D Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References: