Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty

• ClinicalTrials.gov Identifier: NCT02052466
• Recruitment Status: Completed
• First Posted: February 3, 2014
• Results First Posted: February 23, 2017
• Last Update Posted: May 9, 2017
• Sponsor: Eric Ricchetti
• Information provided by (Responsible Party): Eric Ricchetti, The Cleveland Clinic

Study Description

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).

Condition or disease
Osteoarthritis; Rotator Cuff Tear Arthropathy; Reverse Total Shoulder Arthroplasty; Scapular Notching

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

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Prediction of Development of Scapular Notching Based on Glenosphere Positioning, Scapular Morphology, and Simulated Impingement-free Motion Using Three-dimensional Computed Tomography Analysis
• Study Start Date: January 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: October 2016

Groups and Cohorts

Group/Cohort
Reverse TSA patients; Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who had a reverse Total Shoulder Arthroplasty at the Cleveland Clinic from 2004 to 2011 and who had a high quality preoperative CT scan.

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Eric Ricchetti

Investigators

• Principal Investigator: Eric T Ricchetti, MD; The Cleveland Clinic

More Information

Publications:

Iannotti JP, Ricchetti ET, Rodriguez EJ, Bryan JA. Development and validation of a new method of 3-dimensional assessment of glenoid and humeral component position after total shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Oct;22(10):1413-22. doi: 10.1016/j.jse.2013.01.005. Epub 2013 Mar 6.

• Responsible Party: Eric Ricchetti, Staff, Orthopaedic Surgery, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02052466
• Other Study ID Numbers: 12-1244
• First Posted: February 3, 2014
• Results First Posted: February 23, 2017
• Last Update Posted: May 9, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Eric Ricchetti, The Cleveland Clinic:

Shoulder Joint; Computed tomography

Additional relevant MeSH terms:

Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Crystal Arthropathies