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

Active, not recruiting

• Conditions: Hip Arthritis

• Registration Number: NCT02188095
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Study Start: 2014-09-03
• Primary Completion: 2015-10-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient gave written informed consent
• age ≥ 18 years

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival Rate of the Implant	10 years	Kaplan-Meier Survival Rate up to 10 years

Secondary Outcome Measures

Name	Time	Method
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
Stress Shielding	10 years	Radiological documentation of stress shielding 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.
Hypertrophies	10 years	Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years
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

Trial Locations

Locations (2)

Diakonie Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany

Vulpius Klinik; 🇩🇪 Bad Rappenau, Germany