Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture

Summary

This is the world's first national orthopedic randomized controlled trial (RCT) involving 19 out of 21 departments in Denmark. Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. The aim is to compare two surgical treatment methods (metal fixation versus artificial hip) in patients above 65 years with an undisplaced femoral neck fracture. The hypothesis is that even though an artificial hip is a larger surgical procedure than metal fixation of the broken bone, the artificial hip is more stable with less pain due the lack of a healing broken bone and therefore leads to a better and quicker mobilization after surgery. Better mobilization is one of the most important factors for decreasing mortality. We have chosen a pragmatic RCT design by using the local departmental implants. We hope that the knowledge from this study will therefore easily be implemented afterwards.

Conditions

• Undisplaced Fracture
• Femoral Neck Fractures
• Internal Fixation; Complications
• Arthroplasty Complications

Interventions

PROCEDURE

Arthroplasty

Arthroplasty is commonly used for a displaced femoral neck fracture.

PROCEDURE

Internal fixation

Internal fixation is commonly used for undisplaced femoral neck fracture

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• Regionshospital Nordjylland

  collaborator OTHER_GOV

• Aarhus University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Regionshospitalet Viborg, Skive

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Regionshospitalet Horsens

  collaborator OTHER

• Hospital of Southern Jutland

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Nykøbing Falster County Hospital

  collaborator OTHER

• Regional Hospital West Jutland

  collaborator OTHER

• Bornholm Hospital

  collaborator UNKNOWN

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Bjarke Viberg, MD, PhD · Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital

• Ole Brink, MD, PhD · Department of Orthopaedic Surgery and Traumatology, Aarhus University Hospital

• Søren Kold, Professor · Department of Orthopaedic Surgery and Traumatology, Aalborg University Hospital

• Morten S Larsen, MD · Odense University Hospital

• Kristoffer B Hare, MD, PhD · Department of Orthopaedic Surgery and Traumatology, Slagelse Hospital

• Henrik Palm, MD, DmSc · Department of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-01

Primary Completion

2024-01-26

Completion

2025-01-26

Countries

• Denmark

Study Locations