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

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 Overview

• Status: Completed
• Conditions: Hemiarthroplasty; Hip Fractures; Surgical Approach; Posterolateral; Direct Lateral
• Intervention / Treatment: Procedure: Surgical approach

• Study Type: Interventional
• Enrollment (Actual): 555
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1090 hm
      • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Posterolateral; Patients treated with a hemiarthroplasty using the posterolateral approach	Procedure: Surgical approach; The surgical approach of hemiarthroplasty after femoral neck fracture
Experimental: Direct lateral; Patients treated with a hemiarthroplasty using the direct lateral approach	Procedure: Surgical approach; The surgical approach of hemiarthroplasty after femoral neck fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-interventions	Number of patients which are undergoing a re-intervention in the first 6 months after surgery	at 6 months after surgery
SPPB	Balance test (SPPB)	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).	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)	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.	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	at 6 months after surgery
Complications	The number of post-operative complications	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.	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.	at 4 weeks, 3 and 6 months post-operative

Collaborators and Investigators

• Sponsor: JointResearch

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: NL63378.100.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No