NCT02246335

Brief Summary

Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

7 years

First QC Date

September 18, 2014

Last Update Submit

August 29, 2016

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • Harris hip score

    The hip specific outcome score Harris hip score at 2 years will be the main outcome variable

    2 years

Secondary Outcomes (11)

  • EQ-5D

    2 years

  • EQ-5D

    4 years

  • EQ-5D

    6 years

  • EQ-5D

    10 years

  • Adverse events

    2 years

  • +6 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Hemiarthroplasty

Device: Cemented hemiarthroplasty

Treatment group

ACTIVE COMPARATOR

Total hip arthroplasty

Device: Cemented total hip arthroplasty

Interventions

Cemented total hip arthroplastyDEVICE
Treatment group
Cemented hemiarthroplastyDEVICE
Control group

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Acute displaced femoral neck fracture of hip (Garden classification 3-4)
  • Independent walker with or without walking aides
  • Patient willing to participate in the study and give written consent.

You may not qualify if:

  • Fracture older than 36 hours before admission
  • Osteoarthritis in the fractured hip
  • Rheumatoid arthritis in the fractured hip
  • Pathological fractures
  • Contraindication for hip arthroplasty surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

Related Publications (1)

  • Skoldenberg O, Chammout G, Mukka S, Muren O, Nasell H, Hedbeck CJ, Salemyr M. HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 19;16:307. doi: 10.1186/s12891-015-0763-3.

    PMID: 26480938DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Ph D

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 22, 2014

Study Start

October 1, 2009

Primary Completion

October 1, 2016

Study Completion

October 1, 2020

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

SE(1)