Femoral Neck FracturesHIPSTERNCT06096883
Hip Socket Erosion Study
An observational study of Femoral Neck Fractures and Hemiarthroplasty, run by Rijnstate Hospital at 5 sites in Netherlands.
Trial summary
The aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck… Read more about this study
- Who is it for?
- Ages Up to 76 years
- Conditions the study is for
- Femoral Neck Fractures, Hemiarthroplasty, Acetabulum; Protrusion
- How many people
- 134 participants
- Where
- 5 sitesNetherlands
- Study dates
- 19 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 76 years
- All sexes
- Child, Adult, Older adult
Study population: Hospital patients who have received hemiarthroplasty after femoral neck fracture
Who may be able to join
- having had a displaced femoral neck fracture that was subsequently treated with hemiarthroplasty
- aged < 75 years at the time of surgery
- have at least two post-operative radiographs (with at least six weeks between them) available for acetabular erosion measurements.
Who cannot join
- patients diagnosed with rheumatoid arthritis, osteoporosis, hip dysplasia or a previous hip fracture of the ipsilateral hip.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Jeroen Bosch Hospital, Department of Orthopedics
's-Hertogenbosch
Northwest Clinics, Centre for Orthopaedic Research Alkmaar (CORAL) and Department of Orthopaedic Surgery
Alkmaar
Rijnstate Hospital
Arnhem, Gelderland, 6800 WC
Máxima Medical Center, Department of Orthopaedic Surgery
Eindhoven
Isala Hospital, Department of Orthopaedics
Zwolle
About this study
Official title: Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study
The aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck fracture who have received either HA or THA, ii) to explore the proportion of patients after HA who developed acetabular erosion in the first years post-surgery and iii) to explore the proportion of patients after HA for whom acetabular erosion was the main reason for conversion surgery from HA to THA. A secondary objective is to assess the observer reliability of, and explore the association between, the Baker classification grading and Köhler line measurements.
All participants approached for participation in the main phase of the study will be asked to give their written informed consent to use their patient data. Patients who are willing to participate will also be asked to complete a short paper survey to collect data that is not available from their health records.
Read the detailed description
Some orthopaedic surgeons believe that relatively 'young' older patients (aged ≤ 75 years) who have sustained a femoral neck fracture should be treated with hemiarthroplasty (HA) instead of total hip arthroplasty (THA). The rationale behind this belief is that THA is more time consuming, has greater associated surgical morbidity and may increase the risk of hip dislocation and subsequent revision surgery. On the other hand, HA is believed to accelerate acetabular erosion (i.e. wear) over time, which may ultimately lead to the need for conversion surgery from HA to THA. Due to a lack of research in this area, it is unclear how often the development of acetabular erosion in patients after HA actually occurs. This makes it difficult for orthopaedic surgeons to make an informed choice between HA or THA surgery for this patient group.
This is an exploratory retrospective study using existing electronic patient data of patients adhering to the inclusion criteria of the study, i.e. patients of ≤ 75 years of age who have had HA after a femoral neck fracture.
- Medical subject headings
- Femoral Neck Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with acetabular erosion
The proportion of patients after HA who have developed acetabular erosion in the years post-surgery.
Measured: Up to 15 years after index surgery
Secondary outcomes (1)
The frequency of patients who have had conversion surgeries
The number (frequency) of patients who have had conversion surgery after the index surgery.
Measured: Up to 15 years after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start19 Jun 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Isala, Jeroen Bosch Ziekenhuis, Maxima Medical Center, Noordwest Ziekenhuisgroep
- Responsible party
- Sponsor
- Investigators
- Matthijs P. Somford, MD, PhD, Principal investigator, Stichting Rijnstate Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096883
- Sponsor's protocol ID
- 2023-2224
- Acronym
- HIPSTER
- Status last verified
- Jun 2026
- First submitted
- 19 Oct 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Acetabular Erosion After Hemiarthroplasty: an Exploratory Retrospective Study
- ClinicalTrials.gov ID
- NCT06096883
- Acronym / sponsor ID
- HIPSTER / 2023-2224
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Isala, Jeroen Bosch Ziekenhuis, Maxima Medical Center, Noordwest Ziekenhuisgroep
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Oct 2023 (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 aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck fracture who have received either HA or THA, ii) to explore the proportion of patients after HA who developed acetabular erosion in the first years post-surgery and iii) to explore the proportion of patients after HA for whom acetabular erosion was the main reason for conversion surgery from HA to THA. A secondary objective is to assess the observer reliability of, and explore the association between, the Baker classification grading and Köhler line measurements.
All participants approached for participation in the main phase of the study will be asked to give their written informed consent to use their patient data. Patients who are willing to participate will also be asked to complete a short paper survey to collect data that is not available from their health records.
Detailed description
Some orthopaedic surgeons believe that relatively 'young' older patients (aged ≤ 75 years) who have sustained a femoral neck fracture should be treated with hemiarthroplasty (HA) instead of total hip arthroplasty (THA). The rationale behind this belief is that THA is more time consuming, has greater associated surgical morbidity and may increase the risk of hip dislocation and subsequent revision surgery. On the other hand, HA is believed to accelerate acetabular erosion (i.e. wear) over time, which may ultimately lead to the need for conversion surgery from HA to THA. Due to a lack of research in this area, it is unclear how often the development of acetabular erosion in patients after HA actually occurs. This makes it difficult for orthopaedic surgeons to make an informed choice between HA or THA surgery for this patient group.
This is an exploratory retrospective study using existing electronic patient data of patients adhering to the inclusion criteria of the study, i.e. patients of ≤ 75 years of age who have had HA after a femoral neck fracture.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 76 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital patients who have received hemiarthroplasty after femoral neck fracture
Key inclusion criteria (3 listed)
- having had a displaced femoral neck fracture that was subsequently treated with hemiarthroplasty
- aged < 75 years at the time of surgery
- have at least two post-operative radiographs (with at least six weeks between them) available for acetabular erosion measurements.
Key exclusion criteria (1 listed)
- patients diagnosed with rheumatoid arthritis, osteoporosis, hip dysplasia or a previous hip fracture of the ipsilateral hip.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients with acetabular erosion
Time frame: Up to 15 years after index surgery
The proportion of patients after HA who have developed acetabular erosion in the years post-surgery.
1 secondary outcome
The frequency of patients who have had conversion surgeries
Time frame: Up to 15 years after index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Matthijs P. Somford, MD, PhD principal investigator
Stichting Rijnstate Ziekenhuis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures and Hemiarthroplasty, run by Rijnstate Hospital at 5 sites in Netherlands.
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 1 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with acetabular erosion (time frame: Up to 15 years after index surgery). 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 25 Jun 2026.