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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03290807
Other study ID # SPECT/CT in osteoarthritis
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 18, 2017
Last updated September 21, 2017
Start date October 1, 2017
Est. completion date November 2019

Study information

Verified date September 2017
Source Assiut University
Contact Fatma- Elzahraa Mostafa mahmoud
Phone 01095529911
Email fatma.mostafa07@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date November 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
SPECT/CT
Combined single photon emission computerized tomography and conventional computerized tomography (SPECT/CT) is a hybrid imaging modality, which combines a 3D bone scintigraphy (SPECT) and a conventional CT into one imaging procedure. The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
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