Clinical trial NCT04438226: Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral
Official title: Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Surgical Approach
Hemiarthroplasty
Posterolateral
Direct Lateral
Lead sponsor: JointResearch
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: EQ-5D-5L
timeFrame: at 6 months after surgery
Secondary outcomes:
measure: Re-interventions
timeFrame: at 6 months after surgery
measure: SPPB
timeFrame: at 4 months after surgery
measure: FES-I
timeFrame: at 6 months after surgery
measure: NRS
timeFrame: at 6 months after surgery
measure: KATZ
timeFrame: at 6 months after surgery
measure: Mobility
timeFrame: at 6 months after surgery
measure: Complications
timeFrame: During admission, 3 and 6 months post-operative
measure: Discharge destination
timeFrame: After admission, at 3 and 6 months post-operative
measure: Cost-effectiveness
timeFrame: at 4 weeks, 3 and 6 months post-operative
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord Holland
Study officials:
References: