Complications and Functional Outcome of Displaced Femoral Neck Fractures in Patients Younger Than 70 Years

NCT02085707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-01-20

No results posted yet for this study

Summary

Patients younger than 70 years with a displaced femoral neck are in serious conditions. The femoral neck fracture is associated with low activity levels, hip pain and substantially reduced quality of life. Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment, and the health economic aspect a great challenge. In this study the investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy femoral neck fractures treated with a total hip arthroplasty leads to a better functional outcome than osteosynthesis, and can patient-related factors be identified that predispose for femoral fracture? It is a randomized multi center study of patients operated with either total hip arthroplasty or osteosynthesis in which functional outcome, complications and reoperations are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that predispose for displaced femoral neck fractures for patients aged 55 - 70 years. Map bone density measured with Dexa for two types of surgical procedures. Map complications and functional outcome after osteosynthesis or total hip replacement in patients aged 55 - 70 years with displaced femoral neck fractures.

Conditions

Interventions

PROCEDURE

Total hip replacement arthroplasty

treatment with total hip replacement arthroplasty with the implant chosen by the institution

PROCEDURE

Closed reduction and internal fixation

treatment with closed reduction and internal fixation with 2 cannulated hip pins

Sponsors & Collaborators

  • Ullevaal University Hospital

    collaborator OTHER
  • Haukeland University Hospital

    collaborator OTHER
  • Vestre Viken Hospital Trust

    collaborator OTHER
  • Lund University Hospital

    collaborator OTHER
  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Torbjørn Omland, Professor · University Hospital, Akershus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-12-31
Completion
2020-12-31

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085707 on ClinicalTrials.gov