NCT03290807

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 18, 2017

Last Update Submit

September 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

SPECT/CTDEVICE

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)

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient with resolved osteoarthritis.
  • patient with other disease in joints:
  • Avascular necrosis
  • Stress fracture
  • Neuropathic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Central Study Contacts

Fatma- Elzahraa Mostafa mahmoud

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physicians

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 25, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

September 25, 2017

Record last verified: 2017-09