The Role of Tc 99m MDP SPECT/CT in Osteoarthritis

September 21, 2017 updated by: Fatma El-Zahraa Mostafa Mahmoud, Assiut University
Evaluation of the diagnostic value of SPECT/CT in patients with knee and/or hip OA, whether it is related to clinical findings and it could reflect clinical disease activity, and to determine the usefulness of SPECT/CT in early detection of OA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is a slowly developing chronic degenerative joint disease that progresses over years. After the classification and reporting of OA were established by American College of Rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported by plain radiographic findings.

Since X-ray image has a discrepancy with clinical findings, the therapeutic modalities tend to depend on the clinical symptoms, rather than the objective imaging findings.

MRI is a non-invasive and a very sensitive tool in detecting the early bony change such as bone marrow oedema, but it has some limitation in that it may have false positive or false negative results in the detection of the patella-femoral (PF) lesions. Bone scintigraphy is relatively sensitive because it reflects the early physiological changes of joints. But its image is planar that it cannot give enough information for the anatomic localization, and the image is overlapped.

To compensate for the defects of these imaging methods, bone single photon emission computed tomography (SPECT) has emerged as useful imaging tools in the diagnosis of OA.

Based upon the fact that subchondral bony changes precede joint space narrowing in OA, bone SPECT seems to be a very useful tool in early OA, reflecting the early bony changes.

The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT), which represents a relevant improvement in preoperative diagnosis and follow-up after procedures.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Adult patient above 30 years old.
  • Clinically diagnosed osteoarthritis before treatment.
  • Patient with refractory active osteoarthritis (not responding to treatment).
  • Ability to sleep in fixed position for about 25 minutes
  • Ability to provide informed consent.

Description

Inclusion Criteria:

  • Adult patient above 30 years old.
  • Clinically diagnosed osteoarthritis before treatment.
  • Patient with refractory active osteoarthritis (not responding to treatment).
  • Ability to sleep in fixed position for about 25 minutes
  • Ability to provide informed consent.

Exclusion Criteria:

  • Patient with resolved osteoarthritis.

  • patient with other disease in joints:

    • Avascular necrosis
    • Stress fracture
    • Neuropathic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detecting different pattern of osseous MDP uptake in patient with osteoarthritis in hip joints and/or knees in relation to clinical and simple radiographic findings.
Time Frame: Baseline

Osteoarthritic patients will be examined with 99mTc-methylene diphosphonate (MDP) bone SPECT, the sites of uptake will be localized.

Simple radiograph and physical examination will be assessed.The relationships between clinical findings, simple radiographic findings and the intensity of uptake in SPECT will be analyzed.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECT/CT in osteoarthritis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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