Hip Fractures Treated With Uncemented Arthroplasties
HUA
Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
1 other identifier
interventional
140
1 country
1
Brief Summary
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 16, 2015
January 1, 2015
7 years
February 19, 2013
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Harris Hip Score
Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions: Pain, function, absence of deformity and range of motion
12 month
Secondary Outcomes (2)
Health related quality of life
12 month
Radiological follow up
12 month
Other Outcomes (1)
General and surgical complications
from operation until 12 month postoperatively
Study Arms (4)
uncemented hemiarthroplasty
EXPERIMENTALPatients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty
reverse hybrid total hip arthroplasty
EXPERIMENTALPatients aged between 65 and 79 years treated with an reverse hybrid arthroplasty.
cemented hemiarthroplasty
ACTIVE COMPARATORPatients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty
cemented total hip arthroplasty
ACTIVE COMPARATORPatients aged between 65 and 79 years treated with an cemented total hip arthroplasty.
Interventions
Patients aged 80 years and older operated with an cemented hemiarthroplasty. Fixation of the wedge-shaped, polished ChromCobalt steel femoral stem to host bone by use of PolyMetylMetAcrylat bone cement. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.
Patients aged 65 to 79 years operated with an uncemented femoral component combined with cemented acetabular cup. The femoral stem is fixed to the host bone by press-fit technique. We use a tapered, proximally hydroxyapatite coated, titanium stem. The acetabular cup is fixed to the host bone with bone cement. We use an all-polyethylene design. Bone cement consists of PolyMetylMetAcrylat.
Patients aged 65 to 79 years operated with a cemented femoral stem combined with a cemented acetabular cup. Femoral and acetabular component are fixed to the host bone by use of bone cement. The femoral stem is a polished, wedge-shaped design made of ChromCobalt steel. The acetabular cup is fixed to the host bone with bone cement.The acetabular cup an all-polyethylene design. Bone cement consists of PolyMetAcrylat.
Patients aged 80 years and older are randomized to uncemented hemiarthroplasty. Fixation of the tapered, proximally hydroxyapatite coated, titanium stem to the host bone by "press-fit"-technique. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.
Eligibility Criteria
You may qualify if:
- displaced fracture of the femoral neck
- independent living
- independent ambulation (with or without walking aids)
You may not qualify if:
- pathological fracture
- severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
- preexisting ipsilateral hip disease
- neurological disease (e.g. M. Parkinson)
- psychiatric disease which makes understanding or following instructions impossible
- history of drug and alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stockholm South General Hospitallead
- Karolinska Institutetcollaborator
Study Sites (1)
Södersjukhuset (South general hospital), Department of orthopedic surgery
Stockholm, 118 83, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sari Ponzer, M.D. Prof
Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant orthopeadic surgery
Study Record Dates
First Submitted
February 19, 2013
First Posted
February 25, 2013
Study Start
November 1, 2009
Primary Completion
November 1, 2016
Study Completion
November 1, 2018
Last Updated
January 16, 2015
Record last verified: 2015-01