Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly

NCT ID: NCT02246335

Last Updated: 2016-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2020-10-31

Brief Summary

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

Detailed Description

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Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).

Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Hemiarthroplasty

Group Type ACTIVE_COMPARATOR

Cemented hemiarthroplasty

Intervention Type DEVICE

Treatment group

Total hip arthroplasty

Group Type ACTIVE_COMPARATOR

Cemented total hip arthroplasty

Intervention Type DEVICE

Interventions

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Cemented total hip arthroplasty

Intervention Type DEVICE

Cemented hemiarthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Not suitable for inclusion for other reasons e.g. substance abuse
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olof Skoldenberg

Medical Doctor, Ph D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 26480938 (View on PubMed)

Other Identifiers

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HOPE

Identifier Type: -

Identifier Source: org_study_id

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