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OpenTrials
Completed

NCT Number: NCT02188095

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

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

Completed

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Key information

Conditions

Hip Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vulpius Klinik, Bad Rappenau, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient gave written informed consent
  • age ≥ 18 years

Exclusion criteria

  • pregnancy

Treatment and study plan

Primary outcomes

  1. Survival Rate of the Implant

    Time frame: 10 years

    Kaplan-Meier Survival Rate up to 10 years

Secondary outcomes

  1. Hip disability and Osteoarthritis Outcome Score (HOOS)

    Time frame: preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years

    Documentation of clinical outcome with HOOS Score

  2. 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

    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.

  3. Pain Assessment

    Time frame: at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)

    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.

  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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2025
First posted
Jul 11, 2014
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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