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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Arthritis

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • Bad Rappenau, Germany, 74906
    • Vulpius Klinik
  • Stuttgart, Germany, 70176
    • Diakonie Klinikum Stuttgart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

• Patient gave written informed consent
• age ≥ 18 years

Exclusion Criteria:

• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Excia T®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip disability and Osteoarthritis Outcome Score (HOOS)	Documentation of clinical outcome with HOOS Score	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.	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.	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	10 years
Stress Shielding	Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years	10 years
Hypertrophies	Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years	10 years

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Peter Aldinger, Prof. Dr., Diakonie-Klinikum Stuttgart

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2014
• Primary Completion (Actual): October 6, 2015
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimated): July 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: AAG-O-H-1401