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

NCT04438226 | Completed DMC

• 1 other identifier: NL63378.100.17
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Surgical Approach; Hemiarthroplasty; Posterolateral; Direct Lateral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Re-interventions

  at 6 months after surgery

• SPPB

  at 4 months after surgery

• FES-I

  at 6 months after surgery

• NRS

  at 6 months after surgery

• KATZ

  at 6 months after surgery

Study Arms (2)

Posterolateral

EXPERIMENTAL

Patients treated with a hemiarthroplasty using the posterolateral approach

Procedure: Surgical approach

Direct lateral

EXPERIMENTAL

Patients treated with a hemiarthroplasty using the direct lateral approach

Procedure: Surgical approach

Interventions

Surgical approach PROCEDURE

The surgical approach of hemiarthroplasty after femoral neck fracture

Direct lateral; Posterolateral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• JointResearch: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38206628 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 18, 2020
• Study Start: December 1, 2017
• Primary Completion: January 7, 2022
• Study Completion: July 7, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

NL (1)