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

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.

Study Overview

• Status: Recruiting
• Conditions: Revision Total Hip Arthroplasty; Periprosthetic Fracture of Hip
• Intervention / Treatment: Device: Prevision Revision hip endoprosthesis stem implantation

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Kerstin Bergmann; Phone Number: +49746195-; Email: studies@aesculap.de
• Study Contact Backup: Name: Lutz Dreyer, Dr.; Phone Number: +49746195-; Email: studies@aesculap.de

Study Locations

• Germany
  • Hanover, Germany, 30625
    • Recruiting
    • Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7
    • Contact: Henning Windhagen, Prof. Dr.
• United Kingdom
  • Cambridgeshire
    • Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
      • Recruiting
      • Hinchingbrooke Hospital
      • Contact: Vijay Killampalli; Phone Number: +44 1480-8799; Email: vijay.killampalli@nhs.net
      • Principal Investigator: Vijay Killampalli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with indication of a hip revision

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome of the hip revision surgery	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)	after two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier survival	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.; revision for any reason; hip stem revision; aseptic hip stem revision	after two years
EQ-5D-5L Quality of Life	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".	visits after 2 and 5 years
Complications		visits after 2 and 5 years
Patient satisfaction	Patient reported four-scale evaluation: very satisfied; satisfied; unsatisfied; very unsatisfied	visits after 2 and 5 years
Pain (VAS Score)	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	visits after 2 and 5 years
Radiology: Hip stem subsidence	Hip stem subsidence in mm.	visits after 2 and 5 years
Qualitative radiologic assessment	Fracture healing; if radiolucent line > 2 mm, resorption, hypertrophy, cyst	visits after 2 and 5 years

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Henning Windhagen, Prof. Dr., Orthopädische Kliniken im Annastift, MHH

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2034

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Patient-reported outcomes; Clinical performance and safety; Total hip arthroplasty implantation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Periprosthetic Fractures
• Other Study ID Numbers: AAG-O-H-23015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No