Total Hip Arthroplasty RevisionNCT02019433
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
An observational study of Total Hip Arthroplasty Revision, run by Aesculap AG at 3 sites in Germany.
Trial summary
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan® Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty Revision
- What is being tested?
- Structan®
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2012to Dec 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: specialist clinical centre
Who may be able to join
- Minimum age 18 years
- Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment
- Patient consent for study participation
- Physical and mental willingness to participate in the follow-ups
Who cannot join
- Patient not available for follow-up
- Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
- Tumor
- Alcohol- or Drug abuse
- Permanent cortisone therapy
- Clinically relevant infection
- (Planned) pregnancy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charite Campus Berlin Mitte
Berlin, 10117
Klinik am Eichert
Göppingen, 73035
St. Remigius Krankenhaus Opladen
Leverkusen, 51379
About this study
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®
- Conditions
- Total Hip Arthroplasty Revision
- Being tested
- Structan®
- Keywords
- THA, augment, revision, pelvis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structan®Device
| Study group | Role | What they receive |
|---|---|---|
| Structan® | Not described Receives: Device: Structan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rates
Implant survival is analysed at follow-up examinations at 3 and 12 months
Measured: 12 months
Secondary outcomes (6)
Clinical Outcome
Harris Hip Score
Measured: 3 and 12 months
Pain
Visual Analogue Scale (VAS)
Measured: 3 and 12 months
Osteolysis
Radiographic Outcome
Measured: 3 and 12 months
Ossifications
Radiographic Outcome
Measured: 3 and 12 months
Implant Position
Radiographic Outcome
Measured: 3 and 12 months
Migration of Structan®
Radiographic Outcome
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty RevisionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019433
- Sponsor's protocol ID
- AAG-O-H-1212
- Status last verified
- Jan 2017
- First submitted
- 5 Dec 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
- ClinicalTrials.gov ID
- NCT02019433
- Acronym / sponsor ID
- AAG-O-H-1212
- Conditions
- Total Hip Arthroplasty Revision
- Keywords
- THA, augment, revision, pelvis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Dec 2013 (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.
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Structan® | – | Device: Structan® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- specialist clinical centre
Key inclusion criteria (4 listed)
- Minimum age 18 years
- Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment
- Patient consent for study participation
- Physical and mental willingness to participate in the follow-ups
Key exclusion criteria (7 listed)
- Patient not available for follow-up
- Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
- Tumor
- Alcohol- or Drug abuse
- Permanent cortisone therapy
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 |
|---|---|---|
| Structan® | Device | Structan® |
Primary outcome
Implant Survival Rates
Time frame: 12 months
Implant survival is analysed at follow-up examinations at 3 and 12 months
6 secondary outcomes
Clinical Outcome
Time frame: 3 and 12 months
Pain
Time frame: 3 and 12 months
Osteolysis
Time frame: 3 and 12 months
Ossifications
Time frame: 3 and 12 months
Implant Position
Time frame: 3 and 12 months
Migration of Structan®
Time frame: 3 and 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty Revision, run by Aesculap AG at 3 sites 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 4 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: stopped early, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Implant Survival Rates (time frame: 12 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 26 Jan 2017.