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

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ClinicalTrials.gov Identifier: NCT02246335
Recruitment Status : Active, not recruiting
First Posted : September 22, 2014
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital

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

Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Device: Cemented total hip arthroplasty Device: Cemented hemiarthroplasty Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.
Study Start Date : October 2009
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Hemiarthroplasty
Device: Cemented hemiarthroplasty
Active Comparator: Treatment group
Total hip arthroplasty
Device: Cemented total hip arthroplasty



Primary Outcome Measures :
  1. Harris hip score [ Time Frame: 2 years ]
    The hip specific outcome score Harris hip score at 2 years will be the main outcome variable


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: 2 years ]
    Health-related quality of life at 2 years

  2. EQ-5D [ Time Frame: 4 years ]
    Health-related quality of life at 4 years

  3. EQ-5D [ Time Frame: 6 years ]
    Health-related quality of life at 6 years

  4. EQ-5D [ Time Frame: 10 years ]
    Health-related quality of life at 10 years

  5. Adverse events [ Time Frame: 2 years ]
    All hip related adverse events at 2 years

  6. Adverse events [ Time Frame: 4 years ]
    All hip related adverse events at 4 years

  7. Adverse events [ Time Frame: 6 years ]
    All hip related adverse events at 6 years

  8. Adverse events [ Time Frame: 10 years ]
    All hip related adverse events at 10 years

  9. Harris hip score [ Time Frame: 4 years ]
    Harris hip score at 4 years

  10. Harris hip score [ Time Frame: 6 years ]
    Harris hip score at 6 years

  11. Harris hip score [ Time Frame: 10 years ]
    Harris hip score at 10 years



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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246335


Locations
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Sweden
Orthopaedic department, Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olof Skoldenberg, Medical Doctor, Ph D, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT02246335     History of Changes
Other Study ID Numbers: HOPE
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries