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
  Purpose

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 Intervention Phase
Osteoarthritis, Hip
Arthritis, Rheumatoid
Femur Head Necrosis
Procedure: Manual Intervention
Procedure: Navigated Intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 89
Study Start Date: November 2011
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496300

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

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01496300     History of Changes
Other Study ID Numbers: AAG-G-H-1103
Study First Received: December 15, 2011
Last Updated: September 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection

Keywords provided by Aesculap AG:
Navigation OrthoPilot Hip TEP THA

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

ClinicalTrials.gov processed this record on October 23, 2014