Benefit of Orthopedic Navigation in the ARThroplasty of the Hip (BONARTH)

September 2, 2014 updated by: Aesculap AG

Randomised Controlled Double-blind Monocenter Therapy Study Validating the Benefit From Information Provided by Image Free Navigation System on the Precision of the Placement of Acetabular Component in Patients Undergoing Primary THA

This study was initiated to investigate the impact of the computer based image free navigation on the precision of the cup implantation. The implantation of the acetabular component (cup) is known to be a critical step in hip endoprosthetics. The cup position influences significantly the function, the absence of pain and the longevity of the artificial hip joint. The image free navigation system OrthoPilot is used to control the positioning of the cup during surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

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

  • Germany
      • Bünde, Germany, 32257
        • Lukas-Krankenhaus

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for primary cementless total hip endoprosthesis implantation with Bicontact stem and Plasmacup
  • Diagnoses: primary or secondary coxarthrosis, rheumatoid arthritis, femoral head necrosis
  • Age ≥ 50 Years
  • ASA score <4
  • Patient signed the informed consent

Exclusion Criteria:

  • Excessive damage to the hip joint (e.g. dysplasia)
  • Severe deformities of the pelvis, femoral bone or knee
  • Unfeasibility of landmark palpation (e.g. due to adiposity)
  • Acute or chronic infection
  • Pregnancy
  • Patients not available for follow-up-examination at the center
  • Patients exceeding 10 mSv effective radiation dose because of previous scientific or clinical exposition during the past 10 years

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Manual
Manual Implantation of THA
Procedure: Manual Intervention
Implantation of acetabular component without the use of the navigation system information
Other Names:
  • Conventional THA
EXPERIMENTAL: Navigated
Navigated Implantation of THA
Procedure: Navigated Intervention
Navigated implantation of acetabular component using OrthoPilot image free navigation system
Other Names:
  • Computer assisted orthopedic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
Time Frame: 3 months
The ratio of implantations within the intraoperatively adjusted safe zone of Lewinnek (target anteversion +/-10°, target inclination +/-10°), proved by a CT-scan control measurement.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.
Time Frame: 3 months
The ratio of implantations within the intraoperatively determined safe zone of 5° (target anteversion +/-5°, target inclination +/- 5°) Geometric deviation from the target implantation position Range of Motion Harris hip score 3 months postoperative Complication rate until 3 months Correlation of manual and ultrasound registration of the anterior pelvic plane (independent from therapy group) Proposal and validation of a combined Hip Alignment Score for navigated implantation
3 months

Collaborators and Investigators

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

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Hartmuth Kiefer, Prof. Dr., Lukas Krankenhaus Bünde

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

November 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (ESTIMATE)

December 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 2, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-1103

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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