SPECT-CT for Assessment of Total Knee Arthroplasty in Navigated and Non-navigated Total Knee Arthroplasty

October 22, 2018 updated by: Michael Tobias Hirschmann, Kantonsspital Baselland Bruderholz

SPECT-CT for Assessment of Patients Before and After Navigated and Conventional Total Knee Arthroplasty.

By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we want to show wich method has the better outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With SPECT/CT we want to controll the clinical outcome of patients who underwent a navigated or a non-navigated TKR.

Study Type

Observational

Enrollment (Actual)

210

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

  • Switzerland
    • Baselland
      • Bruderholz, Baselland, Switzerland, 4101
        • Kantonsspital Baselland, Bruderholz

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Paitents before and after total knee replacement surgery

Description

Inclusion Criteria:

  • Total Knee prosthesis (primary)
  • >18 years

Exclusion Criteria:

  • pregnancy
  • lactating women
  • endocrine diseases
  • tumour diseases
  • posttraumatic osteoarthritis of the knee
  • previous infection of the knee
  • medicaments which influence the metabolism of the bone

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SPECT/CT before/after navigated TKR
SPECT/CT in patients before and after navigated TKR (assessment of bone tracer uptake, 3D CT component position)
Procedure: TKR
non-navigated versus computer-navigated total knee replacement
SPECT/CT before/after conventional TKR
SPECT/CT in patients before and after conventional TKR (assessment of bone tracer uptake, 3D CT component position)
Procedure: TKR
non-navigated versus computer-navigated total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
which operation method is the best in terms of outcome and SPECT/CT imaging
Time Frame: five years
five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in the post-treatment
Time Frame: five years
five years

Collaborators and Investigators

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

Sponsor

Kantonsspital Baselland Bruderholz

Investigators

  • Principal Investigator: MIchael T. Hirschmann, MD, Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland

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

April 1, 2010

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 23, 2018

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECT/CT-TKR_001_MH
  • 380/09 (Other Identifier: Ethikkommission beider Basel)

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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