Bone Scintigraphy and Unicompartimental Knee Arthroplasty (PUC-INTEVO)

July 13, 2018 updated by: University Hospital, Brest

Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty

Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty

Study Overview

Status

Unknown

Conditions

Detailed Description

Knee osteoarthritis is a very common disease with significant functional consequences. Surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments.

Consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (PUC) is considered.

The scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment.

This study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

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

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest
      • Morlaix, France, 29600
        • Clinique de la Baie

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient over 18 years old undergoing unicompartmental knee arthroplasty (1 or 2 knee) and who accept the study

Description

Inclusion Criteria:

  • patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition

Exclusion Criteria:

  • Under 18 years old/ contraindications for bone scintigraphy/ refusal to participate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modification in surgical strategy according to bone scintigraphy results
Time Frame: 18 months
pourcentage of therapeutic modification according to bone scintigraphy results
18 months

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

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 (ACTUAL)

March 16, 2017

Primary Completion (ACTUAL)

September 16, 2017

Study Completion (ANTICIPATED)

October 11, 2019

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (ACTUAL)

May 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PUC-INTEVO (29BRC17.0027)

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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