Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral

Not Applicable

Completed

• Conditions: Posterolateral; Hemiarthroplasty; Surgical Approach; Hip Fractures; Direct Lateral
• Interventions: Procedure: Surgical approach

• Registration Number: NCT04438226
• Lead Sponsor: JointResearch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Primary Completion: 2022-01-07
• Study Completion: 2022-07-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterolateral	Surgical approach	Patients treated with a hemiarthroplasty using the posterolateral approach
Direct lateral	Surgical approach	Patients treated with a hemiarthroplasty using the direct lateral approach

Primary Outcome Measures

Name	Time	Method
EQ-5D-5L	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).

Secondary Outcome Measures

Name	Time	Method
KATZ	at 6 months after surgery	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.
Mobility	at 6 months after surgery	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
Complications	During admission, 3 and 6 months post-operative	The number of post-operative complications
Discharge destination	After admission, at 3 and 6 months post-operative	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.
NRS	at 6 months after surgery	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)
Re-interventions	at 6 months after surgery	Number of patients which are undergoing a re-intervention in the first 6 months after surgery
SPPB	at 4 months after surgery	Balance test (SPPB)
FES-I	at 6 months after surgery	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).
Cost-effectiveness	at 4 weeks, 3 and 6 months post-operative	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.

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Noord Holland, Netherlands