NCT01601756

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

May 14, 2012

Last Update Submit

May 16, 2012

Conditions

Revision Total Knee Arthroplasty Because ofLooseningInstabilityImpingementor 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 arthroplastynavigationjoint line

Outcome Measures

Primary Outcomes (1)

  • Restoration of Joint Line

    Difference between preoperatively planned and postoperatively achieved joint line

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

Study Arms (2)

navigated revision total knee arthroplasty

EXPERIMENTAL

revision total knee arthroplasty with the aid of a navigation system

Device: navigated revision knee arthroplasty

conventional revision knee arthroplasty

ACTIVE COMPARATOR

revision knee arthroplasty using conventional instruments

Device: conventional revision knee arthroplasty

Interventions

navigated revision knee arthroplastyDEVICE

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).

navigated revision total knee arthroplasty
conventional revision knee arthroplastyDEVICE

revision knee arthroplasty using conventional instruments

conventional revision knee arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for revision knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Department, Charité - University Medicine Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

Central Study Contacts

Georg Matziolis, MD

CONTACT

+49 30 450 615093georg.matziolis@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 18, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

DE(1)