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Trial registered on ANZCTR
Registration number
ACTRN12613000092796
Ethics application status
Approved
Date submitted
17/01/2013
Date registered
24/01/2013
Date last updated
24/01/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Unipolar versus bipolar hemiarthroplasty in displaced intracapsular femoral neck fractures among patients over 65 years: A randomized long-term follow-up study
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Scientific title
Unipolar versus bipolar hemiarthroplasty in displaced femoral neck fractures in elderly patients and the role of different femoral head component in long term survival: a randomized control study.
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Secondary ID [1]
281782
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none
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Universal Trial Number (UTN)
1111-1138-5652
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
hip fracture
288102
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Condition category
Condition code
Surgery
288477
288477
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0
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Surgical techniques
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Musculoskeletal
288513
288513
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0
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Other muscular and skeletal disorders
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Injuries and Accidents
288514
288514
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0
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Fractures
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The difference between unipolar versus bipolar head (Lubinus, Waldemar Link, Hamburg, Germany) in the same stem (Lubinus SPII, Waldemar Link, Hamburg, Germany) when treating femoral neck fractures in elderly patients. This randomized control study wants to investigate whether there is difference in the outcome of mobility or difference in the acetabular erosion leading to revision surgery. Patients with femoral neck fracture will receive a hemiendoprosthesis either with unipolar or bipolar head, 80 minutes surgery time. Primary outcome is revision surgery of any reason, follow-up time is in the minimun 5-years. Survival analyses were performed using Cox regression models. Revision surgery of any reason and complications are stated when occurred and final check-up is done at the end of the study at 30.3.2013.
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Intervention code [1]
286326
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Treatment: Surgery
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Comparator / control treatment
Half of the patients receive bipolar head and half will receive unipolar head. Bipolar head is the group studies with unipolar head as control.
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Control group
Active
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Outcomes
Primary outcome [1]
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Prosthesis survival
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Assessment method [1]
288635
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Timepoint [1]
288635
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Survival analyses were performed using Cox regression models with revision due to any reason as the endpoint. The outcome is assessed continuously and the final check-up is done at the end of the study, which is expected to occur end of january 2013.
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Secondary outcome [1]
300672
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Complications are observed by clinical assessments.
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Assessment method [1]
300672
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Timepoint [1]
300672
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Complications include infection, dislocation, protrusion, periprosthetic fracture. And they will be recorded any time they occur continuously until the end of the study.
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Secondary outcome [2]
300673
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ambulatory ability
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Assessment method [2]
300673
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Timepoint [2]
300673
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2 months, 1,3 and 5 years. Patients are ask how they live. There are six options:
1. Independent community ambulatory with regular exercise
2. Independent community ambulator
3. Independent household ambulator
4. Household ambulator with cane
5. Household ambulator with walker/crutches
6. Assisted ambulation only
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Secondary outcome [3]
300674
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mortality
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Assessment method [3]
300674
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Timepoint [3]
300674
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The date of death will be checked from the health database. This database is updated once a month and the date of the deaths will be checked once a month by coordinating nurse continuing until the end of the follow-up 30.3.2013.
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Eligibility
Key inclusion criteria
Elderly patients over 65 years, displaced femoral neck fracture
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria were (a) age less than sixty five years, (b) fracture of pathological origin (c) non-displaced (Garden I-II) fracture if assumed that patient can follow postoperative weight bearing limitations of internal fixation, (d) alcohol or drug abuse (e) cognitively unintact, (f) known bone diseases or known malignancy, (g) high energy trauma (h) rheumatoid arthritis, (i) osteoarthritis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Analyses of outcome were based on the intention to treat principle, and all patients remained in the group to which that they had been randomized. Data were analyzed using a chi square test for dichotomized measures or Student’s t test for continuous numeric variables. A Cox regression analysis was used to determine survival functions. The level of significance was set at p-value less than 0.05. We used SPSS 18.0 for Windows (IBM, NewYork) for all analyses.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/03/2003
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Actual
9/03/2003
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Date of last participant enrolment
Anticipated
31/12/2006
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Actual
22/06/2006
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4798
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Finland
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State/province [1]
4798
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Tampere
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Funding & Sponsors
Funding source category [1]
286566
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
286566
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Primary sponsor type
Hospital
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Name
Tampere University Hospital
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Address
P.O.Box 2000
33521 Tampere
Finland
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Country
Finland
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Secondary sponsor category [1]
285351
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None
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Name [1]
285351
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Address [1]
285351
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Country [1]
285351
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288633
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Pirkanmaa District Hospital Ethics Committee
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Ethics committee address [1]
288633
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Pirkanmaa District Hospital Ethics Committee
P.O.Box 2000
33521 Tampere
Finland
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Ethics committee country [1]
288633
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Finland
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Date submitted for ethics approval [1]
288633
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Approval date [1]
288633
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Ethics approval number [1]
288633
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R02107
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Summary
Brief summary
The choice between unipolar and bipolar hemiarthroplasty in displaced intracapsular fractures in elderly still remains controversial. Bipolar head has been postulated to decrease the wear of acetabulum thereby diminishing the risk of conversion to total arthroplasty with time. Our objective was to compare series of elderly individuals who sustained a displaced femoral neck fracture treated with either a cemented, modular monopolar prosthesis or a cemented, modular bipolar prosthesis with the same femoral component for at least five years.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Minna Laitinen
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Address
37078
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Department of Orthopedics
Unit of Musculoskeletal Surgery
University Hospital Of Tampere
P.O.Box 2000
33521 Tampere
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Country
37078
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Finland
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Phone
37078
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+358405594598
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Fax
37078
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Email
37078
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[email protected]
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Contact person for public queries
Name
37079
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Mrs Minna Laitinen
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Address
37079
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Department of Orthopedics
Unit of Musculoskeletal Surgery
University Hospital Of Tampere
P.O.Box 2000
33521 Tampere
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Country
37079
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Finland
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Phone
37079
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+358405594598
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Fax
37079
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Email
37079
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[email protected]
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Contact person for scientific queries
Name
37080
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Mrs Minna Laitinen
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Address
37080
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Department of Orthopedics
Unit of Musculoskeletal Surgery
University Hospital Of Tampere
P.O.Box 2000
33521 Tampere
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Country
37080
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Finland
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Phone
37080
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+358405594598
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Fax
37080
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Email
37080
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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