Benefit of Orthopedic Navigation in the ARThroplasty of the Hip (BONARTH)
This study is currently recruiting participants.
Verified February 2013 by Aesculap AG
Sponsor:
Aesculap AG
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01496300
First received: December 15, 2011
Last updated: February 19, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Hip Arthritis, Rheumatoid Femur Head Necrosis |
Procedure: Manual Intervention Procedure: Navigated Intervention |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Aesculap AG:
Primary Outcome Measures:
- Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]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:
- Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system. [ Time Frame: 3 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 89 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: Manual
Manual Implantation of THA
|
Procedure: Manual Intervention
Implantation of acetabular component without the use of the navigation system information
Other Name: Conventional THA
|
|
Experimental: Navigated
Navigated Implantation of THA
|
Procedure: Navigated Intervention
Navigated implantation of acetabular component using OrthoPilot image free navigation system
Other Name: Computer assisted orthopedic surgery
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496300
Contacts
| Contact: Viktor Breul | +49-7461-95-2393 | viktor.breul@aesculap.de |
Locations
| Germany | |
| Lukas-Krankenhaus | Recruiting |
| Bünde, Germany, 32257 | |
| Contact: Keosun Sambo | |
| Principal Investigator: Keosun Sambo | |
| Sub-Investigator: Michael Imort, Dr. | |
| Sub-Investigator: Georgi Wassilew, Dr. | |
Sponsors and Collaborators
Aesculap AG
Investigators
| Principal Investigator: | Hartmuth Kiefer, Prof. Dr. | Lukas-Krankenhaus Bünde |
More Information
No publications provided
| Responsible Party: | Aesculap AG |
| ClinicalTrials.gov Identifier: | NCT01496300 History of Changes |
| Other Study ID Numbers: | AAG-G-H-1103 |
| Study First Received: | December 15, 2011 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Office for Radiation Protection |
Keywords provided by Aesculap AG:
|
Navigation OrthoPilot Hip TEP THA |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Femur Head Necrosis Necrosis Osteoarthritis Osteoarthritis, Hip Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Osteonecrosis Bone Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013