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

This study is currently recruiting participants.

Verified July 2012 by Aesculap AG

Sponsor:

Information provided by (Responsible Party):

Aesculap AG

ClinicalTrials.gov Identifier:

NCT01496300

First received: December 15, 2011

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2011

Last Updated Date

July 16, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01496300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis, Hip
Arthritis, Rheumatoid
Femur Head Necrosis

Intervention ^ICMJE

Procedure: Manual Intervention
Implantation of acetabular component without the use of the navigation system information

Other Name: Conventional THA
Procedure: Navigated Intervention
Navigated implantation of acetabular component using OrthoPilot image free navigation system

Other Name: Computer assisted orthopedic surgery

Study Arm (s)

Sham Comparator: Manual
Manual Implantation of THA

Intervention: Procedure: Manual Intervention
Experimental: Navigated
Navigated Implantation of THA

Intervention: Procedure: Navigated Intervention

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Viktor Breul

+49-7461-95-2393

viktor.breul@aesculap.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01496300

Other Study ID Numbers ^ICMJE

AAG-G-H-1103

Has Data Monitoring Committee

Responsible Party

Aesculap AG

Study Sponsor ^ICMJE

Aesculap AG

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hartmuth Kiefer, Prof. Dr.

Lukas-Krankenhaus Bünde

Information Provided By

Aesculap AG

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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