Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

NCT ID: NCT01601756

Last Updated: 2012-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

navigated revision total knee arthroplasty

revision total knee arthroplasty with the aid of a navigation system

Group Type EXPERIMENTAL

navigated revision knee arthroplasty

Intervention Type DEVICE

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).

conventional revision knee arthroplasty

revision knee arthroplasty using conventional instruments

Group Type ACTIVE_COMPARATOR

conventional revision knee arthroplasty

Intervention Type DEVICE

revision knee arthroplasty using conventional instruments

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

navigated 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).

Intervention Type DEVICE

conventional revision knee arthroplasty

revision knee arthroplasty using conventional instruments

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* indication for revision knee arthroplasty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aesculap AG

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georg Matziolis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orthopaedic Department, Charité - University Medicine Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Georg Matziolis, MD

Role: CONTACT

+49 30 450 615093

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Georg Matziolis, MD

Role: primary

+49 30 450 615093

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAG-I-H-0917

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Robotic Assisted TKA
NCT06062615 COMPLETED NA