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Arthritis, DegenerativeNCT02799654

Excia T Cementless EBRA Study

An observational study of Arthritis, Degenerative and Arthritis, Rheumatoid, run by Aesculap AG at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated. Read more about this study

Who is it for?
Ages 18 years and older
How many people
0 participants
Where
1 siteGermany
Study dates
Aug 2017to Dec 2019
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: Patients with indication for cementless primary Total Hip Arthroplasty

Who may be able to join

  • Written patient consent to study participation
  • Age > 18 years
  • Indication for primary THA with cementless Excia T® stem

Who cannot join

  • Pregnancy
  • THA after fracture
  • Rheumatoid arthritis
  • Systemic disorders, treated with Cortisone or other pharmaceuticals, potentially compromising the bone quality
  • Patient physically or mentally not able to follow the postoperative examination routine

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Prof. Dr. med. E. Mayr

    Celle, 29223

Other trials in Germany

About this study

Official title: Non-Interventional Post Market Clinical Follow-up Study Excia T® Cementless EBRA Study

In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated.

Keywords
Total Hip Arthroplasty
Medical subject headings
Osteoarthritis, Arthritis, Rheumatoid, Hip Fractures, Femur Head Necrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subsidence over time of Excia T® stem (EBRA-FCA)

    The subsidence of the Excia T stem will be measured with Ein-Bild-Röntgen-Analysis Femoral Component Analysis (EBRA-FCA). EBRA allows a non-invasive measurement of routinely taken A/P radiographs. Necessary is a series of at least four x-rays that can be read by the EBRA software.

    The whole implant must be visible on the A/P x-ray, as well as the greater and lesser trochanter.

    Subsidence shall be measured on the follow-up x-rays in comparison to the discharge x-rays.

    Measured: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

Secondary outcomes (8)

  1. Clinical Results over time (Harris Hip Score)

    The clinical assessment will be done with the Harris Hip Score (HHS)

    Measured: preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

  2. Quality of Life over time (EQ-5D-5L)

    The generic patient reported outcome score EQ-5D-5L will be used for the assessment of quality of life.

    Measured: preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

  3. Osteolysis over time (localized bone resorption)

    radiological evaluation will be done according to the (A/P) Gruen zones

    Measured: 3, 12 and 24 months postoperative

  4. Radiolucent lines over time

    radiological evaluation will be done according to the (A/P) Gruen zones: ≤1mm, 1-2mm, ≥2mm

    Measured: 3, 12 and 24 months postoperative

  5. Cortical thinning

    radiological evaluation will be done according to the (A/P) Gruen zones

    Measured: 3, 12 and 24 months postoperative

  6. Hypertrophy

    radiological evaluation will be done according to the (A/P) Gruen zones

    Measured: 3, 12 and 24 months postoperative

  7. Mechanical Alignment over time

    any change of the A/P implant angle (varus / valgus alignment) as assessed with EBRA-FCA will be evaluated

    Measured: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative

  8. Adverse Events / Serious Adverse Events

    Rates of Adverse Events / Serious Adverse Events are recorded

    Measured: until 24 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2016 (estimated)
  2. Study startAug 2017 (estimated)
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2019 (estimated)

Why it stopped: Change of organizational circumstances.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799654
Sponsor's protocol ID
AAG-O-H-1612
Status last verified
Sep 2017
First submitted
6 Jun 2016
Last updated
7 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Degenerative 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 7 Sep 2017. 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. 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 withdrawn before enrolling participants, so there are no results.

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?

Subsidence over time of Excia T® stem (EBRA-FCA) (time frame: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02799654.

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 7 Sep 2017.

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