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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorMilton S. Hershey Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known contraindications to CT/EMG

Inability to provide informed consent

History of recent trauma to the shoulder

Atypical shoulder pain

Trial design

Design model

Single group

Treatments tested in this trial

  • CT scan of the shoulders

    Diagnostic test

    studies of both operative and nonoperative shoulders

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: total shoulder replacement surgeryOther 1 intervention

Trial outcomes

Primary outcomes

1

Active Nerve Denervation

EMG examination will be performed by a single neurologist. The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for any presence or absence of active denervation. Presence indicated by increased insertional activity, fibrillation potential, positive sharp waves and/or with fasciculations in both operated and unoperated shoulders.

Time frame
one year post surgery
2

Active Nerve Denervation

EMG examination will be performed by a single neurologist. The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for any presence or absence of active denervation. Presence indicated by increased insertional activity, fibrillation potential, positive sharp waves and/or with fasciculations in both operated and unoperated shoulders.

Time frame
two year post surgery
3

Neuropathic Changes_amplitude

The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology amplitude: measured in millivolts, in both operated and unoperated shoulders.

Time frame
one year post surgery
4

Neuropathic Changes_amplitude

The EMG Examination will be performed on the muscles (upper subscapularis, supraspinatus, infraspinatus, teres minor and rhomboid) to look for the presence or absence of neuropathic changes assessed by examining unit morphology amplitude: measured in millivolts, in both operated and unoperated shoulders.

Time frame
two year post surgery

Secondary outcomes

1

Tear in Rotator Cuff Muscles in both shoulders

CT Scan to evaluate rotator cuff muscles for presence or absence of any tear in operative and non-operative. If tear is present - partial or full. If full, small or (\<1cm), or medium (1-3 cm\_ or Large (3-5 cm) or massive (\>5cm), tendon involved (supraspinatus or infraspinatus or subscapularis).

Time frame
one year post surgery
2

Tear in Rotator Cuff Muscles in both shoulders

CT Scan to evaluate rotator cuff muscles for presence or absence of any tear in operative and non-operative. If tear is present - partial or full. If full, small or (\<1cm), or medium (1-3 cm\_ or Large (3-5 cm) or massive (\>5cm), tendon involved (supraspinatus or infraspinatus or subscapularis).

Time frame
two year post surgery
3

Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification

CT scan to evaluate atrophy in Rotator Cuff Muscles using the Goutallier Classification System. The Classification system measures fatty tissue infiltration and has five stages, ranging from Stage 0 (normal muscle) to Stage 4 (more fat than muscle) in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid in both operated and unoperated shoulder.

Time frame
one year post surgery
4

Fatty degeneration in Rotator Cuff Muscles in both shoulders using Goutallier Classification

CT scan to evaluate atrophy in Rotator Cuff Muscles using the Goutallier Classification System. The Classification system measures fatty tissue infiltration and has five stages, ranging from Stage 0 (normal muscle) to Stage 4 (more fat than muscle) in upper subscapularis, infraspinatus, supraspinatus, teres minor and rhomboid in both operated and unoperated shoulder.

Time frame
two year post surgery

Other outcomes

1

Forward Elevation for Active Range of Motion

A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.

Time frame
one year post surgery
2

Forward Elevation for Active Range of Motion

A physical exam will be performed on both shoulders to asses forward elevation on active range of motion using a Goniometer.

Time frame
two year post surgery
3

Forward Elevation for Passive Range of Motion

A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.

Time frame
one year post surgery
4

Forward Elevation for Passive Range of Motion

A physical exam will be performed on both shoulders to asses forward elevation for passive range of motion using a Goniometer.

Time frame
two year post surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

Penn State Health Milton S Hershey Medical Center

Sponsor institution