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

Hip Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02188095
• Other study ID #: AAG-O-H-1401
• Status: Active, not recruiting
• Start date: September 3, 2014
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: October 6, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient gave written informed consent

• age = 18 years

Exclusion Criteria:

• pregnancy

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis

Locations

Country	Name	City	State
Germany	Vulpius Klinik	Bad Rappenau
Germany	Diakonie Klinikum Stuttgart	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate of the Implant	Kaplan-Meier Survival Rate up to 10 years	10 years
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	Stress Shielding	Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years	10 years
Secondary	Hypertrophies	Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years	10 years