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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02188095

Enrollment

100

Registered

2014-07-11

Start date

2014-09-03

Completion date

2025-11-07

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthritis

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient gave written informed consent * age ≥ 18 years

Exclusion criteria

* pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Survival Rate of the Implant	10 years	Kaplan-Meier Survival Rate up to 10 years

Secondary

Measure	Time frame	Description
Change of functional outcome over follow-up period (Harris Hip Score (HHS))	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.
Hip disability and Osteoarthritis Outcome Score (HOOS)	preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years	Documentation of clinical outcome with HOOS Score
Shaftposition ap and lateral	10 years	Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years
Stress Shielding	10 years	Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years
Hypertrophies	10 years	Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years
Pain Assessment	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.

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORPeter Aldinger, Prof. Dr.

Diakonie-Klinikum Stuttgart

Outcome results