CClinicalTrials.gg
Status unknownNCT01601756NavRevKnieUpdated May 18, 2012

Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

An interventional study of navigated revision knee arthroplasty and conventional revision knee arthroplasty in Revision Total Knee Arthroplasty Because of, Loosening and Instability, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-18.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).

02

Conditions studied

  • Revision Total Knee Arthroplasty Because of
  • Loosening
  • Instability
  • Impingement
  • or Other Reasons Accepted as Indications for TKA Exchange.
  • The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty

Keywords

  • revision knee arthroplasty
  • navigation
  • joint line
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • indication for revision knee arthroplasty
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    navigated revision total knee arthroplasty

    revision total knee arthroplasty with the aid of a navigation system

    Device: navigated revision knee arthroplasty

  • Active comparator
    conventional revision knee arthroplasty

    revision knee arthroplasty using conventional instruments

    Device: conventional revision knee arthroplasty

Interventions

  • Devicenavigated revision knee arthroplasty

    revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).

  • Deviceconventional revision knee arthroplasty

    revision knee arthroplasty using conventional instruments

06

What researchers measure

Primary outcomes

  1. Restoration of Joint Line

    Difference between preoperatively planned and postoperatively achieved joint line

    Time frame: postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)

07

Study locations

1 of 1 sites recruiting
  • Orthopaedic Department, Charité - University Medicine Berlin
    Berlin, 10117, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01601756
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Aesculap AG
Responsible party
Georg Matziolis (Professor, Charite University, Berlin, Germany) — Principal investigator
First posted
May 18, 2012
Start date
Sep 2011
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
May 18, 2012

Study contacts

Georg Matziolis, MD
Contact
georg.matziolis@charite.de
+49 30 450 615093

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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