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

Trial Summary

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 data supports the effectiveness of CT scans after shoulder replacement for shoulder osteoarthritis?

CT scans can help identify complications after shoulder replacement, such as mechanical issues and infections, which can guide further treatment and improve outcomes. ^{1 2 3 4 5}

Is it safe to have a CT scan after shoulder replacement surgery?

CT scans are generally safe and commonly used to check for complications after shoulder replacement surgery. They help doctors see if there are any issues with the shoulder implant, like loosening or infection, without causing harm to the patient. ^{1 2 6 7 8}

How is the CT scan treatment different for shoulder osteoarthritis after replacement surgery?

CT scans are used to precisely evaluate the position and stability of shoulder implants after replacement surgery, which can help identify complications like loosening or infection that might not be visible with standard X-rays. This makes CT scans a valuable tool for diagnosing issues that cause pain or dysfunction in patients with shoulder replacements. ^{1 8 9 10 11}

What is the purpose of this trial?

The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.

Research Team

April D Armstrong, MD

Principal Investigator

Milton S. Hershey Medical Center

Eligibility Criteria

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.

My primary diagnosis is shoulder osteoarthritis.

I am able to understand and agree to the study's procedures and risks.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

SPECT/CT in Postoperative Shoulder Pain. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Incidence of complications related to shoulder arthroplasties identified on computed tomography. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Shoulder arthroplasty in osteoarthritis: correlation between function and radiographic parameters. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Osteoporosis and shoulder osteoarthritis: incidence, risk factors, and surgical implications. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Shoulder joint arthroplasty in young patients: Analysis of 8742 patients from the Australian Orthopaedic Association National Joint Replacement Registry. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Imaging in an academic orthopedic shoulder service: a report on incidental lung pathology findings. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Core Set of Radiographic Parameters for Shoulder Arthroplasty Monitoring: Criteria Defined by an International Delphi Consensus Process. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Imaging of shoulder arthroplasties and their complications: a pictorial review. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic assessment of glenoid component loosening after total shoulder arthroplasty. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Sequential 3-dimensional computed tomography analysis of implant position following total shoulder arthroplasty. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Assessment of painful total shoulder arthroplasty using computed tomography arthrography. [2019]