Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

Arthritis, Rheumatoid Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496300
• Other study ID #: AAG-G-H-1103
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2011
• Last updated: September 2, 2014
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Federal Office for Radiation Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Femur Head Necrosis
• Osteoarthritis, Hip

Intervention

Procedure:
• Manual Intervention
Implantation of acetabular component without the use of the navigation system information
• Navigated Intervention
Navigated implantation of acetabular component using OrthoPilot image free navigation system

Locations

Country	Name	City	State
Germany	Lukas-Krankenhaus	Bünde

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	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	3 months	No