OsteoarthritisNCT02052466
Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
An observational study of Osteoarthritis and Rotator Cuff Tear Arthropathy, run by Eric Ricchetti at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Conditions
- Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty, Scapular Notching
- Keywords
- Shoulder Joint, Computed tomography
- Medical subject headings
- Osteoarthritis, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 24 months after reverse TSA
Secondary outcomes (11)
Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)
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.
Measured: At least 24 months after reverse TSA
Shoulder Strength - Flexion
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.
Measured: At least 24 months after TSA
Shoulder Strength - Abduction
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.
Measured: At least 24 months after TSA
Shoulder Strength - Internal Rotation
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.
Measured: At least 24 months after TSA
Shoulder Strength - External Rotation
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.
Measured: At least 24 months after TSA
Active Shoulder Range of Motion - Flexion
Flexion
Measured: At least 24 months after reverse TSA
Active Shoulder Range of Motion - Abduction
Abduction
Measured: At least 24 months after reverse TSA
Active Shoulder Range of Motion - External Rotation
External rotation
Measured: At least 24 months after reverse TSA
Passive Shoulder Range of Motion - Flexion
Flexion
Measured: At least 24 months after reverse TSA
Passive Shoulder Range of Motion - Abduction
Abduction
Measured: At least 24 months after reverse TSA
Passive Shoulder Range of Motion - External Rotation
External rotation
Measured: At least 24 months after reverse TSA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Ricchetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Ricchetti, The Cleveland Clinic
- Investigators
- Eric T Ricchetti, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052466
- Sponsor's protocol ID
- 12-1244
- Status last verified
- May 2017
- First submitted
- 29 Jan 2014
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23473609
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02052466
- Acronym / sponsor ID
- 12-1244
- Conditions
- Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty, Scapular Notching
- Keywords
- Shoulder Joint, Computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eric RicchettiUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)
Time frame: At least 24 months after reverse TSA
Shoulder Strength - Flexion
Time frame: At least 24 months after TSA
Shoulder Strength - Abduction
Time frame: At least 24 months after TSA
Shoulder Strength - Internal Rotation
Time frame: At least 24 months after TSA
Shoulder Strength - External Rotation
Time frame: At least 24 months after TSA
Active Shoulder Range of Motion - Flexion
Time frame: At least 24 months after reverse TSA
Active Shoulder Range of Motion - Abduction
Time frame: At least 24 months after reverse TSA
Active Shoulder Range of Motion - External Rotation
Time frame: At least 24 months after reverse TSA
Passive Shoulder Range of Motion - Flexion
Time frame: At least 24 months after reverse TSA
Passive Shoulder Range of Motion - Abduction
Time frame: At least 24 months after reverse TSA
Passive Shoulder Range of Motion - External Rotation
Time frame: At least 24 months after reverse TSA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23473609Iannotti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric T Ricchetti, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rotator Cuff Tear Arthropathy, run by Eric Ricchetti at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual Versus Predicted Scapular Notching (time frame: At least 24 months after reverse TSA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.