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Completed

NCT Number: NCT02052466

Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

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).

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Key information

Conditions

Osteoarthritis Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Reverse Total Shoulder Arthroplasty Rheumatic Diseases Rotator Cuff Tear Arthropathy Scapular Notching

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Actual Versus Predicted Scapular Notching

    Time frame: 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 outcomes

  1. Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)

    Time frame: 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.

  2. Shoulder Strength - Flexion

    Time frame: 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.

  3. Shoulder Strength - Abduction

    Time frame: 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.

  4. Shoulder Strength - Internal Rotation

    Time frame: 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.

  5. Shoulder Strength - External Rotation

    Time frame: 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.

  6. Active Shoulder Range of Motion - Flexion

    Time frame: At least 24 months after reverse TSA

    Flexion

  7. Active Shoulder Range of Motion - Abduction

    Time frame: At least 24 months after reverse TSA

    Abduction

  8. Active Shoulder Range of Motion - External Rotation

    Time frame: At least 24 months after reverse TSA

    External rotation

  9. Passive Shoulder Range of Motion - Flexion

    Time frame: At least 24 months after reverse TSA

    Flexion

  10. Passive Shoulder Range of Motion - Abduction

    Time frame: At least 24 months after reverse TSA

    Abduction

  11. Passive Shoulder Range of Motion - External Rotation

    Time frame: At least 24 months after reverse TSA

    External rotation

Sponsors and collaborators

Lead sponsor

Eric Ricchetti

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 3, 2014
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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