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

Primary Purpose

Osteoarthritis, Hip, Arthritis, Rheumatoid, Femur Head Necrosis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Manual Intervention
Navigated Intervention
Sponsored by
Aesculap AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Navigation OrthoPilot Hip TEP THA

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lukas-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Manual

Navigated

Arm Description

Manual Implantation of THA

Navigated Implantation of THA

Outcomes

Primary Outcome Measures

Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
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.
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

Full Information

First Posted
December 15, 2011
Last Updated
September 2, 2014
Sponsor
Aesculap AG
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1. Study Identification

Unique Protocol Identification Number
NCT01496300
Brief Title
Benefit of Orthopedic Navigation in the ARThroplasty of the Hip
Acronym
BONARTH
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Arthritis, Rheumatoid, Femur Head Necrosis
Keywords
Navigation OrthoPilot Hip TEP THA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual
Arm Type
Sham Comparator
Arm Description
Manual Implantation of THA
Arm Title
Navigated
Arm Type
Experimental
Arm Description
Navigated Implantation of THA
Intervention Type
Procedure
Intervention Name(s)
Manual Intervention
Other Intervention Name(s)
Conventional THA
Intervention Description
Implantation of acetabular component without the use of the navigation system information
Intervention Type
Procedure
Intervention Name(s)
Navigated Intervention
Other Intervention Name(s)
Computer assisted orthopedic surgery
Intervention Description
Navigated implantation of acetabular component using OrthoPilot image free navigation system
Primary Outcome Measure Information:
Title
Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmuth Kiefer, Prof. Dr.
Organizational Affiliation
Lukas Krankenhaus Bünde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lukas-Krankenhaus
City
Bünde
ZIP/Postal Code
32257
Country
Germany

12. IPD Sharing Statement

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Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

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