Revision Total Hip ArthroplastyPREMONCT06626490
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
An observational study of Revision Total Hip Arthroplasty and Periprosthetic Fracture of Hip, run by Aesculap AG at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip
- What is being tested?
- Prevision Revision hip endoprosthesis stem implantation
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Apr 2026to Mar 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication of a hip revision
Who may be able to join
- Revision hip arthroplasty patients treated with a Prevision hip stem
- Written patient informed consent
- Patients are able to attend at follow-up examinations
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7
Hanover, 30625
Henning Windhagen, Prof. Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, PE29 6NT
Vijay Killampalli, +44 1480-8799, vijay.killampalli@nhs.net
Vijay Killampalli
About this study
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.
Read the 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.
- Being tested
- Prevision Revision hip endoprosthesis stem implantation
- Keywords
- Patient-reported outcomes, Clinical performance and safety, Total hip arthroplasty implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevision Revision hip endoprosthesis stem implantationDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: after two years
Secondary outcomes (7)
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
Measured: 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".
Measured: visits after 2 and 5 years
Complications
Measured: visits after 2 and 5 years
Patient satisfaction
Patient reported four-scale evaluation:
- very satisfied
- satisfied
- unsatisfied
- very unsatisfied
Measured: 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
Measured: visits after 2 and 5 years
Radiology: Hip stem subsidence
Hip stem subsidence in mm.
Measured: visits after 2 and 5 years
Qualitative radiologic assessment
Fracture healing; if radiolucent line > 2 mm, resorption, hypertrophy, cyst
Measured: visits after 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Apr 2026
- Primary completionMar 2033 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Windhagen, Prof. Dr., Principal investigator, Orthopädische Kliniken im Annastift, MHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626490
- Sponsor's protocol ID
- AAG-O-H-23015
- Acronym
- PREMO
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
- ClinicalTrials.gov ID
- NCT06626490
- Acronym / sponsor ID
- PREMO / AAG-O-H-23015
- Keywords
- Patient-reported outcomes, Clinical performance and safety, Total hip arthroplasty implantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Mar 2033 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication of a hip revision
Key inclusion criteria (3 listed)
- Revision hip arthroplasty patients treated with a Prevision hip stem
- Written patient informed consent
- Patients are able to attend at follow-up examinations
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevision Revision hip endoprosthesis stem implantationThe 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. | Device | – |
Primary outcome
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)
7 secondary outcomes
Kaplan-Meier survival
Time frame: after two years
EQ-5D-5L Quality of Life
Time frame: visits after 2 and 5 years
Complications
Time frame: visits after 2 and 5 years
Patient satisfaction
Time frame: visits after 2 and 5 years
Pain (VAS Score)
Time frame: visits after 2 and 5 years
Radiology: Hip stem subsidence
Time frame: visits after 2 and 5 years
Qualitative radiologic assessment
Time frame: visits after 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henning Windhagen, Prof. Dr. principal investigator
Orthopädische Kliniken im Annastift, MHH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision Total Hip Arthroplasty and Periprosthetic Fracture of Hip, run by Aesculap AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerstin Bergmann (+49746195- ext. 0, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome of the hip revision surgery (time frame: after two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.