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Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty (CHANCE)

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ClinicalTrials.gov Identifier: NCT02247791
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : January 28, 2016
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Olof Skoldenberg, Danderyd Hospital

Brief Summary:
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

Condition or disease Intervention/treatment Phase
Hip Fractures Procedure: Uncemented femoral stem Procedure: Cemented femoral stem Not Applicable

Detailed Description:
The study will randomize patients between an uncemented and cemented stem

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip
Study Start Date : September 2009
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cemented femoral stem
Patient undergoing total hip arthroplasty surgery
Procedure: Cemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Other Name: CPT cemented femoral stem

Active Comparator: Uncemented femoral stem
Patients undergoing total hip arthroplasty
Procedure: Uncemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Other Name: BiMetric uncemented femoral stem




Primary Outcome Measures :
  1. Hip related complication rate [ Time Frame: 2 years ]
    All hip-related complications

  2. Health-related Quality of Life [ Time Frame: 2 years ]
    Health related quality of life


Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: 2 years ]
  2. Intraoperative bleeding [ Time Frame: 2 years ]
  3. Hip function [ Time Frame: 2 years ]
    Measured with Harris hip score



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Displaced femoral neck fracture
  • Subject is aged between 65-79 years
  • Independent walker with or without walking aides
  • Subject is able and capable of providing consent to participate in the study

Exclusion Criteria:

  • Patients with Rheumatoid Arthritis
  • Patients with an impaired cognitive dysfunction
  • Patients with Pathological fractures
  • Patients with substance abuse
  • Patients with fracture older than 36-hours on arrival at the A&E
  • Patients suffering from cancer
  • Patients determined by principal investigator to be unsuitable for inclusion

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): NCT02247791


Locations
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Sweden
Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Zimmer Biomet
Investigators
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Principal Investigator: Ghazi Chammout, MD Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olof Skoldenberg, Director of research, Orthopaedic dept, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT02247791     History of Changes
Other Study ID Numbers: CHANCE
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries