Back to resultsUncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty (CHANCE)
Primary Purpose
Hip Fractures
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Uncemented femoral stem
Cemented femoral stem
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility 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
Sites / Locations
- Danderyd Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cemented femoral stem
Uncemented femoral stem
Arm Description
Patient undergoing total hip arthroplasty surgery
Patients undergoing total hip arthroplasty
Outcomes
Primary Outcome Measures
Hip related complication rate
All hip-related complications
Health-related Quality of Life
Health related quality of life
Secondary Outcome Measures
Duration of surgery
Intraoperative bleeding
Hip function
Measured with Harris hip score
Full Information
NCT ID
NCT02247791
First Posted
October 21, 2013
Last Updated
January 27, 2016
Sponsor
Danderyd Hospital
Collaborators
Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT02247791
Brief Title
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty
Acronym
CHANCE
Official Title
Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study will randomize patients between an uncemented and cemented stem
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cemented femoral stem
Arm Type
Active Comparator
Arm Description
Patient undergoing total hip arthroplasty surgery
Arm Title
Uncemented femoral stem
Arm Type
Active Comparator
Arm Description
Patients undergoing total hip arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Uncemented femoral stem
Other Intervention Name(s)
BiMetric uncemented femoral stem
Intervention Description
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Intervention Type
Procedure
Intervention Name(s)
Cemented femoral stem
Other Intervention Name(s)
CPT cemented femoral stem
Intervention Description
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Primary Outcome Measure Information:
Title
Hip related complication rate
Description
All hip-related complications
Time Frame
2 years
Title
Health-related Quality of Life
Description
Health related quality of life
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of surgery
Time Frame
2 years
Title
Intraoperative bleeding
Time Frame
2 years
Title
Hip function
Description
Measured with Harris hip score
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazi Chammout, MD
Organizational Affiliation
Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
27646142
Citation
Chammout G, Muren O, Boden H, Salemyr M, Skoldenberg O. Cemented compared to uncemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly: study protocol for a single-blinded, randomized controlled trial (CHANCE-trial). BMC Musculoskelet Disord. 2016 Sep 20;17(1):398. doi: 10.1186/s12891-016-1253-y.
Results Reference
derived
Learn more about this trial
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty
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