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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01496300

Acronym

BONARTH

Enrollment

Registered

2011-12-21

Start date

2011-11-30

Completion date

2013-09-30

Last updated

2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid, Femur Head Necrosis, Osteoarthritis, Hip

Keywords

Navigation OrthoPilot Hip TEP THA

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.

Interventions

PROCEDUREManual Intervention

Implantation of acetabular component without the use of the navigation system information

PROCEDURENavigated Intervention

Navigated implantation of acetabular component using OrthoPilot image free navigation system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation	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

Measure	Time frame	Description
Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026