NCT02358447

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

7.3 years

First QC Date

January 2, 2015

Last Update Submit

October 22, 2018

Conditions

OsteoarthritisX-rays; Effects

Keywords

total knee arthroplastytotal knee prothesisSpectrometry, X-Ray EmissionSPECT/CTmeasurement of TKA component position

Outcome Measures

Primary Outcomes (1)

  • which operation method is the best in terms of outcome and SPECT/CT imaging

    five years

Secondary Outcomes (1)

  • Improvement in the post-treatment

    five years

Study Arms (2)

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

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

Interventions

TKRPROCEDURE

non-navigated versus computer-navigated total knee replacement

SPECT/CT before/after conventional TKRSPECT/CT before/after navigated TKR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Paitents before and after total knee replacement surgery

You may qualify if:

  • Total Knee prosthesis (primary)
  • \>18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland, Bruderholz

Bruderholz, Basel-Landschaft, 4101, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • MIchael T. Hirschmann, MD

    Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

January 2, 2015

First Posted

February 9, 2015

Study Start

April 1, 2010

Primary Completion

July 1, 2017

Study Completion

October 23, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

CH(1)