Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral
NCT ID: NCT04438226
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
555 participants
INTERVENTIONAL
2017-12-01
2022-07-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Posterolateral
Patients treated with a hemiarthroplasty using the posterolateral approach
Surgical approach
The surgical approach of hemiarthroplasty after femoral neck fracture
Direct lateral
Patients treated with a hemiarthroplasty using the direct lateral approach
Surgical approach
The surgical approach of hemiarthroplasty after femoral neck fracture
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Surgical approach
The surgical approach of hemiarthroplasty after femoral neck fracture
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
JointResearch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL63378.100.17
Identifier Type: -
Identifier Source: org_study_id