Benefit of Orthopedic Navigation in the ARThroplasty of the Hip

NCT ID: NCT01496300

Last Updated: 2014-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Osteoarthritis, Hip Arthritis, Rheumatoid Femur Head Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Manual

Manual Implantation of THA

Group Type SHAM_COMPARATOR

Manual Intervention

Intervention Type PROCEDURE

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

Navigated

Navigated Implantation of THA

Group Type EXPERIMENTAL

Navigated Intervention

Intervention Type PROCEDURE

Navigated implantation of acetabular component using OrthoPilot image free navigation system

Interventions

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Manual Intervention

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

Intervention Type PROCEDURE

Navigated Intervention

Navigated implantation of acetabular component using OrthoPilot image free navigation system

Intervention Type PROCEDURE

Other Intervention Names

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Conventional THA Computer assisted orthopedic surgery

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hartmuth Kiefer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Lukas Krankenhaus Bünde

Locations

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Lukas-Krankenhaus

Bünde, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-G-H-1103

Identifier Type: -

Identifier Source: org_study_id

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