Hip FracturesAPOLLONCT04438226
Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral
A study testing Surgical approach in people with Hip Fractures and Surgical Approach, run by JointResearch at 1 site in Netherlands.
Trial summary
Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the posterolateral and the direct lateral approach. Currently there is no conclusive evidence which of these two approaches results in better patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Surgical Approach, Hemiarthroplasty
- What is being tested?
- Surgical approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2017to 7 Jul 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years at time of trauma
- Acute hip fracture
- Hemiarthroplasty as recommended treatment according the national guidelines
- Dutch or English fluency and literacy
- Informed consent or by proxy in patients with mental impairment
Who cannot join
- Multi-trauma-patient (ISS > 15)
- Secondary surgery after failed internal fixation
- Patients with a known metastatic disease and a confirmed pathological fracture of the hip
- Fracture > 7 days at time of surgery
- High risk of non-compliance/adherence to study procedures (e.g. no Dutch residency during follow-up period, or other factors that impair follow-up data collection)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM
About this study
Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the posterolateral and the direct lateral approach. Currently there is no conclusive evidence which of these two approaches results in better patient outcomes.
Objective: Assessing the patient outcome comparing the posterolateral with the direct lateral approach in patients being treated with cemented hemiarthroplasty after femoral neck fractures.
Read more
Study design: A randomised controlled multi-center superiority trial and natural experiment with an economic evaluation alongside.
Study population: All patients older than 18 years with a femoral neck fracture whereby treatment with cemented hemiarthroplasty is recommended according the national guidelines.
Intervention: Treatment with cemented hemiarthroplasty using the posterolateral approach.
Standard intervention to be compared to: Treatment with cemented hemiarthroplasty using the direct lateral approach.
Main study parameters/endpoints: The primary outcome is the patient-rated quality of life (EQ-5D-5L) at 6 months after surgery.
Secondary outcomes are: ADL functionality (KATZ), Balance test (SPPB), Tendency to Fall (FES-I), Pain (NRS), Re-interventions, Mobility, Discharge destination, Complications, and cost-effectiveness.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The different approaches in the two treatment arms of the randomised controlled trial are widely used techniques in the Netherlands and many of the outcome measures are part of the standard clinical follow-up after hip fracture. Therefore, there is no extra risk or burden for participating patients, except for the time to complete some additional follow-up measurements. The primary outcome measurement and secondary outcomes, will be assessed through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months postoperatively. The assessment of the Short Physical Performance Battery (SPPB) balance test, will be performed by one of the study researchers or nurse practitioner to protect continuity and feasibility.
- Being tested
- Surgical approach
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical approachProcedure or surgery
The surgical approach of hemiarthroplasty after femoral neck fracture
| Study group | Role | What they receive |
|---|---|---|
| Posterolateral | Experimental | Patients treated with a hemiarthroplasty using the posterolateral approach Receives: Procedure: Surgical approach |
| Direct lateral | Experimental | Patients treated with a hemiarthroplasty using the direct lateral approach Receives: Procedure: Surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L
The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: at 6 months after surgery
Secondary outcomes (9)
Re-interventions
Number of patients which are undergoing a re-intervention in the first 6 months after surgery
Measured: at 6 months after surgery
SPPB
Balance test (SPPB)
Measured: at 4 months after surgery
FES-I
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about fallingduring 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The minimum score is 16 (no concern about falling) to the maximum score of 64 (severe concern about falling).
Measured: at 6 months after surgery
NRS
Numeric Rating Scale (NRS) is a numeric scale to assess pain. The minimum score is 0 (no pain) and the maximum score is 10 (the worst imaginable pain)
Measured: at 6 months after surgery
KATZ
Katz Index of Independence in Activities of Daily Living (ADL) is an instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Measured: at 6 months after surgery
Mobility
Mobility according to the mobility score. We'll assess the mobility according to the following options: no walking aids, 1 walking stick, walker or two crutches, in-house mobility but outside no mobility without aids, no functional mobility
Measured: at 6 months after surgery
Complications
The number of post-operative complications
Measured: During admission, 3 and 6 months post-operative
Discharge destination
Discharge destination: We'll ask where the patient is going to live after discharge, which we compare with the place where the patient was living before the trauma. The options are: independently at home, at home with care, nursing home, rehabilitation center.
Measured: After admission, at 3 and 6 months post-operative
Cost-effectiveness
An economic evaluation will be performed for physical functioning and Quality Adjusted Life Years (QALYs). For estimating QALYs, the patients' EQ-5D-5L health states will be converted into utility scores using the Dutch tariff. QALYs will subsequently be calculated using linear interpolation between measurement points.
Measured: at 4 weeks, 3 and 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Dec 2017
- Primary completion7 Jan 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438226
- Sponsor's protocol ID
- NL63378.100.17
- Acronym
- APOLLO
- Status last verified
- Dec 2022
- First submitted
- 11 Jun 2019
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tol MCJM, Willigenburg NW, Rasker AJ, Willems HC, Gosens T, Heetveld MJ, Schotanus MGM, Eggen B, Kormos M, van der Pas SL, van der Vaart AW, Goslings JC, Poolman RW; APOLLO Research Group. Posterolateral or Direct Lateral Surgical Approach for Hemiarthroplasty After a Hip Fracture: A Randomized Clinical Trial Alongside a Natural Experiment. JAMA Netw Open. 2024 Jan 2;7(1):e2350765. doi: 10.1001/jamanetworkopen.2023.50765.
PubMed 38206628
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral
- ClinicalTrials.gov ID
- NCT04438226
- Acronym / sponsor ID
- APOLLO / NL63378.100.17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 18 Jun 2020 (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.
Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the posterolateral and the direct lateral approach. Currently there is no conclusive evidence which of these two approaches results in better patient outcomes.
Objective: Assessing the patient outcome comparing the posterolateral with the direct lateral approach in patients being treated with cemented hemiarthroplasty after femoral neck fractures.
Study design: A randomised controlled multi-center superiority trial and natural experiment with an economic evaluation alongside.
Study population: All patients older than 18 years with a femoral neck fracture whereby treatment with cemented hemiarthroplasty is recommended according the national guidelines.
Intervention: Treatment with cemented hemiarthroplasty using the posterolateral approach.
Standard intervention to be compared to: Treatment with cemented hemiarthroplasty using the direct lateral approach.
Main study parameters/endpoints: The primary outcome is the patient-rated quality of life (EQ-5D-5L) at 6 months after surgery.
Secondary outcomes are: ADL functionality (KATZ), Balance test (SPPB), Tendency to Fall (FES-I), Pain (NRS), Re-interventions, Mobility, Discharge destination, Complications, and cost-effectiveness.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The different approaches in the two treatment arms of the randomised controlled trial are widely used techniques in the Netherlands and many of the outcome measures are part of the standard clinical follow-up after hip fracture. Therefore, there is no extra risk or burden for participating patients, except for the time to complete some additional follow-up measurements. The primary outcome measurement and secondary outcomes, will be assessed through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months postoperatively. The assessment of the Short Physical Performance Battery (SPPB) balance test, will be performed by one of the study researchers or nurse practitioner to protect continuity and feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterolateral | Experimental | Procedure: Surgical approachPatients treated with a hemiarthroplasty using the posterolateral approach |
| Direct lateral | Experimental | Procedure: Surgical approachPatients treated with a hemiarthroplasty using the direct lateral approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years at time of trauma
- Acute hip fracture
- Hemiarthroplasty as recommended treatment according the national guidelines
- Dutch or English fluency and literacy
- Informed consent or by proxy in patients with mental impairment
Key exclusion criteria (5 listed)
- Multi-trauma-patient (ISS > 15)
- Secondary surgery after failed internal fixation
- Patients with a known metastatic disease and a confirmed pathological fracture of the hip
- Fracture > 7 days at time of surgery
- High risk of non-compliance/adherence to study procedures (e.g. no Dutch residency during follow-up period, or other factors that impair follow-up data collection)
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 |
|---|---|---|
| Surgical approachThe surgical approach of hemiarthroplasty after femoral neck fracture | Procedure or surgery | Direct lateral, Posterolateral |
Primary outcome
EQ-5D-5L
Time frame: at 6 months after surgery
The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
9 secondary outcomes
Re-interventions
Time frame: at 6 months after surgery
SPPB
Time frame: at 4 months after surgery
FES-I
Time frame: at 6 months after surgery
NRS
Time frame: at 6 months after surgery
KATZ
Time frame: at 6 months after surgery
Mobility
Time frame: at 6 months after surgery
Complications
Time frame: During admission, 3 and 6 months post-operative
Discharge destination
Time frame: After admission, at 3 and 6 months post-operative
Cost-effectiveness
Time frame: at 4 weeks, 3 and 6 months post-operative
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 21 Dec 2022.
- Derived from this study: PubMed 38206628Tol MCJM, Willigenburg NW, Rasker AJ, Willems HC, Gosens T, Heetveld MJ, Schotanus MGM, Eggen B, Kormos M, van der Pas SL, van der Vaart AW, Goslings JC, Poolman RW; APOLLO Research Group. Posterolateral or Direct Lateral Surgical Approach for Hemiarthroplasty After a Hip Fracture: A Randomized Clinical Trial Alongside a Natural Experiment. JAMA Netw Open. 2024 Jan 2;7(1):e2350765. doi: 10.1001/jamanetworkopen.2023.50765.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical approach in people with Hip Fractures and Surgical Approach, run by JointResearch at 1 site 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 5 inclusion and 5 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
EQ-5D-5L (time frame: at 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438226, which also lists 1 linked publication.
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 21 Dec 2022.