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OpenTrials
Completed

NCT Number: NCT01496300

Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Femur Head Necrosis Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lukas-Krankenhaus

Bünde, 32257, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Intervention

Procedure

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

Other names: Conventional THA

Navigated Intervention

Procedure

Navigated implantation of acetabular component using OrthoPilot image free navigation system

Other names: Computer assisted orthopedic surgery

Primary outcomes

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

    Time frame: 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 outcomes

  1. Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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

Acronym: BONARTH

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 21, 2011
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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