Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06626490

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Revision Total Hip Arthroplasty Periprosthetic Fracture of Hip

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7, Hanover, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevision Revision hip endoprosthesis stem implantation

Device

The Prevision hip endoprosthetic stem is a femoral part of a hip joint endoprosthesis. The system provides cementless and cemented variants. Prevision hip stems are modular with a short proximal and longer distal component, or monobloc hip stems. Modular components are coupled via a Prevision specific conical connection with a torque wrench and a tension nut to apply a predefined torsional moment on the connection. The distal component of modular Prevision stems can be combined with locking screws for additional bone fixation.

Both types, the monobloc and the modular, provide a 12/14 taper that serves as a connection for metal or ceramic prosthesis heads. Prevision hip stems are combined at the acetabulum with a cementless or cemented acetabular cup.

Primary outcomes

  1. Functional outcome of the hip revision surgery

    Time frame: 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 outcomes

  1. Kaplan-Meier survival

    Time frame: 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.

    • revision for any reason
    • hip stem revision
    • aseptic hip stem revision

  2. EQ-5D-5L Quality of Life

    Time frame: 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".

  3. Complications

    Time frame: visits after 2 and 5 years

  4. Patient satisfaction

    Time frame: visits after 2 and 5 years

    Patient reported four-scale evaluation:

    • very satisfied
    • satisfied
    • unsatisfied
    • very unsatisfied

  5. Pain (VAS Score)

    Time frame: 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

  6. Radiology: Hip stem subsidence

    Time frame: visits after 2 and 5 years

    Hip stem subsidence in mm.

  7. Qualitative radiologic assessment

    Time frame: visits after 2 and 5 years

    Fracture healing; if radiolucent line > 2 mm, resorption, hypertrophy, cyst

Study contacts

Contact information is provided by the study sponsor or research team.

Kerstin Bergmann

CONTACT

[email protected]

+49746195-

Lutz Dreyer, Dr.

CONTACT

[email protected]

+49746195-

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Acronym: PREMO

Important dates

Study start
2026
Primary completion
2033
Study completion
2034
First posted
Oct 3, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.