Osteoarthritis, HipPhase 4BONARTHNCT01496300
Benefit of Orthopedic Navigation in the ARThroplasty of the Hip
A Phase 4 study testing Manual Intervention and Navigated Intervention in people with Osteoarthritis, Hip and Arthritis, Rheumatoid, run by Aesculap AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Femur Head Necrosis
- What is being tested?
- Manual Intervention and Navigated Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Manual Intervention, Navigated Intervention
- Keywords
- Navigation OrthoPilot Hip TEP THA
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual InterventionProcedure or surgery
Also called Conventional THA
Implantation of acetabular component without the use of the navigation system information
Navigated InterventionProcedure or surgery
Also called Computer assisted orthopedic surgery
Navigated implantation of acetabular component using OrthoPilot image free navigation system
| Study group | Role | What they receive |
|---|---|---|
| Manual | Sham comparator | Manual Implantation of THA Receives: Procedure: Manual Intervention |
| Navigated | Experimental | Navigated Implantation of THA Receives: Procedure: Navigated Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
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.
Measured: 3 months
Secondary outcomes (1)
Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hartmuth Kiefer, Prof. Dr., Principal investigator, Lukas Krankenhaus Bünde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496300
- Sponsor's protocol ID
- AAG-G-H-1103
- Acronym
- BONARTH
- Status last verified
- Sep 2014
- First submitted
- 15 Dec 2011
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01496300
- Acronym / sponsor ID
- BONARTH / AAG-G-H-1103
- Keywords
- Navigation OrthoPilot Hip TEP THA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual | Sham comparator | Procedure: Manual InterventionManual Implantation of THA |
| Navigated | Experimental | Procedure: Navigated InterventionNavigated Implantation of THA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual InterventionAlso: Conventional THAImplantation of acetabular component without the use of the navigation system information | Procedure or surgery | Manual |
| Navigated InterventionAlso: Computer assisted orthopedic surgeryNavigated implantation of acetabular component using OrthoPilot image free navigation system | Procedure or surgery | Navigated |
Primary outcome
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.
1 secondary outcome
Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hartmuth Kiefer, Prof. Dr. principal investigator
Lukas Krankenhaus Bünde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manual Intervention and Navigated Intervention in people with Osteoarthritis, Hip and Arthritis, Rheumatoid, run by Aesculap AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.