Hip ArthritisNCT02188095
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
An observational study of Hip Arthritis, run by Aesculap AG at 2 sites in Germany.
Trial summary
Clinical and radiological 10 year results of Excia T® Hip Stem Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Sep 2014to 7 Nov 2025
- 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: primary care clinic
Who may be able to join
- Patient gave written informed consent
- age ≥ 18 years
Who cannot join
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Vulpius Klinik
Bad Rappenau, 74906
Diakonie Klinikum Stuttgart
Stuttgart, 70176
About this study
Clinical and radiological 10 year results of Excia T® Hip Stem
- Conditions
- Hip Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Excia T® | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate of the Implant
Kaplan-Meier Survival Rate up to 10 years
Measured: 10 years
Secondary outcomes (6)
Hip disability and Osteoarthritis Outcome Score (HOOS)
Documentation of clinical outcome with HOOS Score
Measured: preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years
Change of functional outcome over follow-up period (Harris Hip Score (HHS))
The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities.
Measured: at discharge, after 3 and 12 months 3, 5 and 10 years
Pain Assessment
Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients are asked to mark their current pain level on the line.
Measured: at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)
Shaftposition ap and lateral
Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years
Measured: 10 years
Stress Shielding
Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years
Measured: 10 years
Hypertrophies
Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start3 Sep 2014
- Primary completion6 Oct 2015
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Aldinger, Prof. Dr., Principal investigator, Diakonie-Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188095
- Sponsor's protocol ID
- AAG-O-H-1401
- Status last verified
- Feb 2026
- First submitted
- 26 Jun 2014
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
- ClinicalTrials.gov ID
- NCT02188095
- Acronym / sponsor ID
- AAG-O-H-1401
- Conditions
- Hip Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 6 Oct 2015 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 11 Jul 2014 (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.
Clinical and radiological 10 year results of Excia T® Hip Stem
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excia T® | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- Patient gave written informed consent
- age ≥ 18 years
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival Rate of the Implant
Time frame: 10 years
Kaplan-Meier Survival Rate up to 10 years
6 secondary outcomes
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years
Change of functional outcome over follow-up period (Harris Hip Score (HHS))
Time frame: at discharge, after 3 and 12 months 3, 5 and 10 years
Pain Assessment
Time frame: at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)
Shaftposition ap and lateral
Time frame: 10 years
Stress Shielding
Time frame: 10 years
Hypertrophies
Time frame: 10 years
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 2 Mar 2026.
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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.
Peter Aldinger, Prof. Dr. principal investigator
Diakonie-Klinikum Stuttgart
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthritis, run by Aesculap AG at 2 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 2 inclusion and 1 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Survival Rate of the Implant (time frame: 10 years). 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 2 Mar 2026.