Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants

Not yet recruiting

• Conditions: Revision Total Hip Arthroplasty; Periprosthetic Fracture of Hip

• Registration Number: NCT06626490
• Lead Sponsor: Aesculap AG

Brief Summary

The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

Detailed Description

Generally, the advantage of the Prevision implant family is that all implant variants can be implanted with basically the same instrumentation, which makes it easier to switch to another variant. All implant variants will be available at the study sites and switching between the variants in the study will be encouraged.

The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation, and comparable revision hip stems. In addition, the patient groups treated with the different variants, and outcome of these subgroups will be descriptively compared.

Study Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Study Start: 2025-06
• Primary Completion: 2032-06
• Study Completion: 2033-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Revision hip arthroplasty patients treated with a Prevision hip stem
• Written patient informed consent
• Patients are able to attend at follow-up examinations

Exclusion Criteria

• Patients < 18 years at surgery
• Pregnancy at implantation
• Patients held in a custodial setting
• Patients in a relationship of dependence on the sponsor, the clinic or the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome of the hip revision surgery	after two years	Oxford Hip Score:The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement (THR)

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier survival	after two years	Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected until the last follow-up of the study patients took place.; 1. revision for any reason; 2. hip stem revision; 3. aseptic hip stem revision
EQ-5D-5L Quality of Life	visits after 2 and 5 years	EQ-5D is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
Complications	visits after 2 and 5 years
Patient satisfaction	visits after 2 and 5 years	Patient reported four-scale evaluation: * very satisfied; * satisfied; * unsatisfied; * very unsatisfied
Pain (VAS Score)	visits after 2 and 5 years	VAS Pain at Rest: 0-100, lower is better; VAS Pain under load: 0-100, lower is better; Patients are asked to mark a point on the line that corresponds to their current level of pain. This mark is then measured and converted into a numerical value, usually between 0 and 10 or 0 and 100, where 0 indicates no pain and the highest value indicates the most severe pain
Radiology: Hip stem subsidence	visits after 2 and 5 years	Hip stem subsidence in mm.
Qualitative radiologic assessment	visits after 2 and 5 years	Fracture healing; if radiolucent line \> 2 mm, resorption, hypertrophy, cyst

Trial Locations

Locations (1)

Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7; 🇩🇪 Hannover, Germany