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

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Aesculap

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis, Hip
Femur Head Necrosis
Arthritis, Rheumatoid

Treatments

Procedure: Navigated Intervention
Procedure: Manual Intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT01496300
AAG-G-H-1103

Details and patient eligibility

About

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.

Enrollment

89 patients

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

89 participants in 2 patient groups

Manual
Sham Comparator group
Description:
Manual Implantation of THA
Treatment:
Procedure: Manual Intervention
Navigated
Experimental group
Description:
Navigated Implantation of THA
Treatment:
Procedure: Navigated Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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