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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01496300
First received: December 15, 2011
Last updated: September 2, 2014
Last verified: September 2014

December 15, 2011
September 2, 2014
November 2011
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01496300 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Benefit of Orthopedic Navigation in the ARThroplasty of the Hip
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis, Hip
  • Arthritis, Rheumatoid
  • Femur Head Necrosis
  • 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
  • Sham Comparator: Manual
    Manual Implantation of THA
    Intervention: Procedure: Manual Intervention
  • Experimental: Navigated
    Navigated Implantation of THA
    Intervention: Procedure: Navigated Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
September 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01496300
AAG-G-H-1103
No
Aesculap AG
Aesculap AG
Not Provided
Principal Investigator: Hartmuth Kiefer, Prof. Dr. Lukas-Krankenhaus Bünde
Aesculap AG
September 2014

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