CT Scans After Shoulder Replacement for Shoulder Osteoarthritis

Overseen By Padmavathi Ponnuru, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Recent trauma, Atypical pain, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the rotator cuff muscles in the shoulder change one and two years after total shoulder replacement surgery. Participants will undergo a CT scan, which provides detailed images of the shoulder. Suitable candidates for this trial are over 45 years old, have shoulder osteoarthritis, and underwent surgery by Dr. Armstrong. Participants should speak and read English fluently and have no recent shoulder injuries or other shoulder conditions.

As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could improve future shoulder replacement outcomes.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that CT scans are safe for assessing shoulder replacement outcomes?

Research has shown that CT scans are generally safe for patients after shoulder replacement surgery. They help doctors identify any issues with the new shoulder joint.

CT scans are widely used in medical imaging, and their safety is well-established. Although they involve exposure to a small amount of radiation, this level is considered safe for most people. Studies have not found any serious side effects specifically linked to CT scans after shoulder surgery.

Overall, CT scans offer a reliable way to monitor recovery and ensure everything is progressing well without posing significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of CT scans to assess outcomes after shoulder replacement surgery for osteoarthritis. Unlike traditional methods that primarily rely on physical assessments and X-rays, CT scans can provide a more detailed, three-dimensional view of the shoulder joint. This allows for a more precise evaluation of how well the shoulder replacement is functioning over time. By using CT scans, researchers hope to gain better insights into the success of the surgery and potentially improve patient outcomes in the future.

What evidence suggests that CT scans are effective for assessing shoulder osteoarthritis after replacement surgery?

Research shows that shoulder replacement surgery can lead to good to excellent results for people with shoulder arthritis. Studies have found that patients often experience significant pain relief and improved shoulder movement after the surgery. One study found that patients improved their shoulder function score to an average of 72.8 out of 100, indicating better shoulder use. This trial will assess outcomes following total shoulder replacement surgery. Both Total Shoulder Arthroplasty (TSA) and Reverse Shoulder Arthroplasty (RSA) have effectively restored shoulder function, with noticeable improvements in shoulder scores. These positive results suggest that shoulder replacement can be a helpful treatment for reducing pain and improving shoulder function. ^{6 7 8 9 10}

Who Is on the Research Team?

April D Armstrong, MD

Principal Investigator

Milton S. Hershey Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals over 45 years old with a primary diagnosis of shoulder osteoarthritis, who had their total shoulder replacement performed by Dr. Armstrong using local anesthetic. Participants must be fluent in English and able to give informed consent.

Inclusion Criteria

I received a local anesthetic, not regional anesthesia.

Fluent in written and spoken English

My primary diagnosis is shoulder osteoarthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total shoulder replacement surgery

1 day

Post-Surgery Assessment

Participants are assessed for outcome measures at one year post-surgery

1 year

1 visit (in-person)

Follow-up Assessment

Participants are assessed for outcome measures at two years post-surgery

1 year

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT scan of the shoulders

Trial Overview

The study aims to assess the condition of rotator cuff muscles after total shoulder replacement surgery using CT scans at one and two years post-operation.

How Is the Trial Designed?

Group I: total shoulder replacement surgery Experimental Treatment 1 Intervention

Subjects will be assessed for the outcome measures at one year and two year timepoints post total shoulder replacement surgery

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

In a study of 21 patients who underwent shoulder arthroplasty, significant improvements were observed in all functional assessments, including flexion, abduction, and overall shoulder function as measured by the Constant-Murley and UCLA scales.

The study found that superior migration of the humerus was correlated with poorer clinical outcomes, indicating that this radiographic parameter may be an important factor in assessing the success of shoulder arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoulder arthroplasty in osteoarthritis: correlation between function and radiographic parameters. Gracitelli, ME., Duarte, FA., Toffoli, RP., et al.[2021]

In a study of 812 CT scans from 797 patients who underwent shoulder arthroplasties, 64.9% of patients experienced complications, with loosening or aseptic osteolysis being the most common at 36.9%.

Total shoulder arthroplasties (TSA) had the highest complication rate at 75.7%, while reverse total shoulder arthroplasties (rTSA) showed significant rates of periprosthetic fractures and dislocations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of complications related to shoulder arthroplasties identified on computed tomography. Cooper, KS., Powell, GM., Baffour, FI., et al.[2023]

In a study of nine patients, arthroscopy was found to accurately diagnose glenoid component loosening in all cases, highlighting its effectiveness in evaluating painful total shoulder arthroplasty.

Radiographic methods, including plain radiographs and arthrography, were less reliable, correlating with component loosening in only a few patients, suggesting that arthroscopy should be the preferred evaluation technique for this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic assessment of glenoid component loosening after total shoulder arthroplasty. Bonutti, PM., Hawkins, RJ., Saddemi, S.[2022]

In a study of 20 patients who underwent total shoulder arthroplasty (TSA), 35% showed signs of glenoid components at risk of loosening after a minimum of 2 years, with component shifts primarily in inclination and retroversion.

The study found a strong association between glenoid component shift and grade 1 central peg osteolysis, with 83% of patients experiencing shift also showing signs of osteolysis, indicating a potential risk for implant failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential 3-dimensional computed tomography analysis of implant position following total shoulder arthroplasty. Ricchetti, ET., Jun, BJ., Cain, RA., et al.[2018]

In patients under 55 years old, total shoulder arthroplasty and reverse total shoulder arthroplasty showed no significant difference in revision rates, indicating both options are similarly reliable for younger patients.

Reverse total shoulder arthroplasty demonstrated a lower revision rate compared to hemi resurfacing and hemiarthroplasty after 2 years, and it had the lowest overall revision rate in patients aged 55-64 years, suggesting it may be the preferred option for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoulder joint arthroplasty in young patients: Analysis of 8742 patients from the Australian Orthopaedic Association National Joint Replacement Registry. McBride, AP., Ross, M., Duke, P., et al.[2023]

SPECT/CT imaging is valuable for diagnosing mechanical complications in shoulder replacements, such as glenoiditis, glenoidal loosening, and scapular notching, which can help guide treatment decisions.

For detecting infections in shoulder prostheses, the combination of labeled white blood cell scintigraphy and bone marrow scintigraphy is considered the reference standard, while FDG-PET can be used when results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECT/CT in Postoperative Shoulder Pain. Thélu-Vanysacker, M., Frédéric, P., Charles-Edouard, T., et al.[2018]

A standardized imaging protocol was developed for monitoring asymptomatic patients after shoulder arthroplasty, based on expert consensus from 98 surgeons, ensuring comprehensive assessment of potential complications.

The protocol includes specific radiographic parameters and a recommended imaging schedule, with 78% of panel members agreeing on the need for imaging at 6 weeks, 3-6 months, and 12 months post-surgery, which could enhance early detection of issues that may require revision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core Set of Radiographic Parameters for Shoulder Arthroplasty Monitoring: Criteria Defined by an International Delphi Consensus Process. Durchholz, H., Salomonsson, B., Moroder, P., et al.[2022]

Shoulder prosthesis implantation is becoming more common, and radiologists must be familiar with the different types of shoulder arthroplasties (reverse, total, and partial) and their specific complications to effectively manage patient care.

Common complications across all shoulder prostheses include infection and loosening, while specific issues like instability and scapular notching are unique to reverse shoulder arthroplasties, highlighting the importance of targeted imaging and diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of shoulder arthroplasties and their complications: a pictorial review. Combes, D., Lancigu, R., Desbordes de Cepoy, P., et al.[2020]

In a study of 14 patients with suspected glenoid component loosening after shoulder arthroplasty, CT arthrography (CTA) indicated loosening in 57.1% of cases, while arthroscopic inspection confirmed loosening in 71.4% of cases, highlighting CTA's potential utility in diagnosing component stability.

However, CTA demonstrated a low negative predictive value of 50%, meaning that a negative result (suggesting stability) does not reliably indicate true stability, as some patients with a well-fixed component were found to have gross loosening during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of painful total shoulder arthroplasty using computed tomography arthrography. Mallo, GC., Burton, L., Coats-Thomas, M., et al.[2019]

In a review of 363 pre-operative shoulder CT scans over 14 years, 0.8% of the scans revealed primary lung cancer, highlighting the importance of monitoring for incidental pulmonary findings during shoulder arthroplasty planning.

4% of the CT scans showed pulmonary findings that were not concerning for malignancy, indicating that while incidental findings are common, most do not pose a significant risk and can be managed with further imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging in an academic orthopedic shoulder service: a report on incidental lung pathology findings. Wengle, L., White, LM., Naraghi, A., et al.[2023]

The study of 230 patients undergoing total shoulder arthroplasty found a significant correlation between CT-derived Hounsfield unit (HU) measurements and bone mineral density (BMD), indicating that HU values can help identify patients with osteoporosis or osteopenia.

Surgeons can use HU measurements from shoulder CT scans to predict the need for larger humeral stem sizes and cement fixation methods, which may improve surgical outcomes for patients with low BMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoporosis and shoulder osteoarthritis: incidence, risk factors, and surgical implications. Pervaiz, K., Cabezas, A., Downes, K., et al.[2016]

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