Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

Prediction of Development of Scapular Notching Based on Glenosphere Positioning, Scapular Morphology, and Simulated Impingement-free Motion Using Three-dimensional Computed Tomography Analysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02052466

Enrollment

Registered

2014-02-03

Start date

2014-01-31

Completion date

2016-10-31

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Reverse Total Shoulder Arthroplasty, Rotator Cuff Tear Arthropathy, Scapular Notching

Keywords

Shoulder Joint, Computed tomography

Brief summary

The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is predictive of the location of clinical scapular notching that develops following reverse total shoulder arthroplasty (TSA).

Detailed description

The Specific Aims are: * Determine the relationship between lateral glenoid offset and the development of scapular notching following reverse TSA * Determine the ability of 3-D preoperative planning tools to define areas of scapular bony impingement on kinematic simulated shoulder range of motion that predict the development of scapular notching * Compare the precision and accuracy of plain radiographs (2-D) versus CT (3-D) for measurement of scapular notching and postoperative implant position following reverse TSA (2-D versus 3-D) * Determine the implant and anatomic factors that best correlate with clinical outcome following reverse TSA by retrospective analysis

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* All patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and a minimum of two years out from surgery

Exclusion criteria

* All patients having undergone reverse TSA at the Cleveland Clinic with no preoperative CT or a low quality preoperative CT of the operative shoulder and/or less than two years from surgery

Design outcomes

Primary

Measure	Time frame	Description
Actual Versus Predicted Scapular Notching	At least 24 months after reverse TSA	At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.

Secondary

Measure	Time frame	Description
Shoulder Strength - Flexion	At least 24 months after TSA	Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.
Shoulder Strength - Abduction	At least 24 months after TSA	Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.
Shoulder Strength - Internal Rotation	At least 24 months after TSA	Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.
Shoulder Strength - External Rotation	At least 24 months after TSA	Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.
Active Shoulder Range of Motion - Flexion	At least 24 months after reverse TSA	Flexion
Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)	At least 24 months after reverse TSA	The Penn Shoulder Score is a shoulder-specific patient reported outcome measure. Best possible score is 100; worst possible score is 0. There are 3 sub-scores: pain (3 questions, 30 possible points), satisfaction (1 question, 10 possible points), and function (20 questions, 60 possible points). Total score is the sum of the 3 sub-scores. For all sub-scores, higher is better. The pain questions are based on a 10-point numeric rating scale. Points are added for the pain sub-score. The satisfaction question asks the patient to rate their satisfaction with their shoulder. It is based on a 10-point numeric rating scale, with 0 as not satisfied and 10 as very satisfied. The function sub-score has 20 questions concerning activities of daily living. The response options are: 0 (can't do at all), 1 (can do with much difficulty), 2 (can do with some difficulty) and 3 (can do with no difficulty). If all activities can be done without difficulty, a score of 60 is achieved.
Active Shoulder Range of Motion - External Rotation	At least 24 months after reverse TSA	External rotation
Passive Shoulder Range of Motion - Flexion	At least 24 months after reverse TSA	Flexion
Passive Shoulder Range of Motion - Abduction	At least 24 months after reverse TSA	Abduction
Passive Shoulder Range of Motion - External Rotation	At least 24 months after reverse TSA	External rotation
Active Shoulder Range of Motion - Abduction	At least 24 months after reverse TSA	Abduction

Countries

United States

Participant flow

Participants by arm

Arm	Count
Reverse TSA Patients Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.	30
Total	30

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Acromial fracture	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Reverse TSA Patients
Age, Continuous	71.08 years STANDARD_DEVIATION 6.06
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	16 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 30
serious Total, serious adverse events	6 / 30

Outcome results

Primary

Actual Versus Predicted Scapular Notching

At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.