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Status unknownNCT04154202Updated Nov 6, 2019

The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.

An interventional study of Bone Scan in Bone Infection, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-11-06.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

Study summary

This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening.

The proposed study will be presented to the ethical committee of the medical center and will be started once approved.

02

Conditions studied

  • Bone Infection
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In context

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.

Exclusion criteria

Exclusion Criteria:

  1. Patients younger than 18 years;
  2. Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (\<3 months) fractures around the prosthesis;
  3. Pathological fractures (e.g. Metastatic).
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Bone inaction patients

    Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.

    Other: Bone Scan

Interventions

  • OtherBone Scan

    Bone Scan: three-phase planar Bone Scan and a SPECT/CT \[perfusion, blood pool and SPECT/CT of the relevant region of interest (ROI), and a whole-body planar late bone scan\].

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What researchers measure

Primary outcomes

  1. To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools..

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04154202
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Nov 6, 2019
Start date
Nov 15, 2019 (estimated)
Primary completion
Jan 15, 2020 (estimated)
Completion
Nov 15, 2021 (estimated)
Last update
Nov 6, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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