Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

Phase 4

Completed

• Conditions: Osteoarthritis, Hip; Arthritis, Rheumatoid; Femur Head Necrosis
• Interventions: Procedure: Navigated Intervention; Procedure: Manual Intervention

• Registration Number: NCT01496300
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-21
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-02
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigated	Navigated Intervention	Navigated Implantation of THA
Manual	Manual Intervention	Manual Implantation of THA

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Lukas-Krankenhaus; 🇩🇪 Bünde, Germany