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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496300
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : September 3, 2014
Information provided by (Responsible Party):
Aesculap AG

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Arthritis, Rheumatoid Femur Head Necrosis Procedure: Manual Intervention Procedure: Navigated Intervention Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

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 Name: Conventional THA

Experimental: Navigated
Navigated Implantation of THA
Procedure: Navigated Intervention
Navigated implantation of acetabular component using OrthoPilot image free navigation system
Other Name: Computer assisted orthopedic surgery

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496300

Bünde, Germany, 32257
Sponsors and Collaborators
Aesculap AG
Principal Investigator: Hartmuth Kiefer, Prof. Dr. Lukas-Krankenhaus Bünde

Responsible Party: Aesculap AG Identifier: NCT01496300     History of Changes
Other Study ID Numbers: AAG-G-H-1103
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014

Keywords provided by Aesculap AG:
Navigation OrthoPilot Hip TEP THA

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis, Hip
Femur Head Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases