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Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188095
Recruitment Status : Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:
Clinical and radiological 10 year results of Excia T® Hip Stem

Condition or disease
Hip Arthritis

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
Actual Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : July 2025

Group/Cohort
Excia T®



Primary Outcome Measures :
  1. Survival Rate of the Implant [ Time Frame: 10 years ]
    Kaplan-Meier Survival Rate up to 10 years


Secondary Outcome Measures :
  1. Hip disability and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 10 years ]
    Documentation of clinical outcome with HOOS Score preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years

  2. Harris Hip Score (HHS) [ Time Frame: 10 years ]
    Documentation of clinical outcome with Harris Hip Score preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years

  3. Pain [ Time Frame: 10 years ]
    Measurement of Pain with Visual Analogue Scale (VAS) preoperatively, intraoperatively + discharge, after 3 and 12 months and 3, 5, and 10 years

  4. Shaftposition ap and lateral [ Time Frame: 10 years ]
    Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years

  5. Stress Shielding [ Time Frame: 10 years ]
    Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years

  6. Hypertrophies [ Time Frame: 10 years ]
    Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • Patient gave written informed consent
  • age ≥ 18 years

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188095


Locations
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Germany
Vulpius Klinik
Bad Rappenau, Germany, 74906
Diakonie Klinikum Stuttgart
Stuttgart, Germany, 70176
Sponsors and Collaborators
Aesculap AG
Investigators
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Principal Investigator: Peter Aldinger, Prof. Dr. Diakonie Klinikum Stuttgart
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT02188095    
Other Study ID Numbers: AAG-O-H-1401
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases