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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
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.
Secondary ID [1] 281782 0
none
Universal Trial Number (UTN)
1111-1138-5652
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip fracture 288102 0
Condition category
Condition code
Surgery 288477 288477 0 0
Surgical techniques
Musculoskeletal 288513 288513 0 0
Other muscular and skeletal disorders
Injuries and Accidents 288514 288514 0 0
Fractures

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286326 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 288635 0
Prosthesis survival
Timepoint [1] 288635 0
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.
Secondary outcome [1] 300672 0
Complications are observed by clinical assessments.
Timepoint [1] 300672 0
Complications include infection, dislocation, protrusion, periprosthetic fracture. And they will be recorded any time they occur continuously until the end of the study.
Secondary outcome [2] 300673 0
ambulatory ability
Timepoint [2] 300673 0
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
Secondary outcome [3] 300674 0
mortality
Timepoint [3] 300674 0
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.

Eligibility
Key inclusion criteria
Elderly patients over 65 years, displaced femoral neck fracture
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4798 0
Finland
State/province [1] 4798 0
Tampere

Funding & Sponsors
Funding source category [1] 286566 0
Self funded/Unfunded
Name [1] 286566 0
Address [1] 286566 0
Country [1] 286566 0
Primary sponsor type
Hospital
Name
Tampere University Hospital
Address
P.O.Box 2000
33521 Tampere
Finland
Country
Finland
Secondary sponsor category [1] 285351 0
None
Name [1] 285351 0
Address [1] 285351 0
Country [1] 285351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288633 0
Pirkanmaa District Hospital Ethics Committee
Ethics committee address [1] 288633 0
Pirkanmaa District Hospital Ethics Committee
P.O.Box 2000
33521 Tampere
Finland
Ethics committee country [1] 288633 0
Finland
Date submitted for ethics approval [1] 288633 0
Approval date [1] 288633 0
Ethics approval number [1] 288633 0
R02107

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37078 0
Mrs Minna Laitinen
Address 37078 0
Department of Orthopedics
Unit of Musculoskeletal Surgery
University Hospital Of Tampere
P.O.Box 2000
33521 Tampere
Country 37078 0
Finland
Phone 37078 0
+358405594598
Fax 37078 0
Email 37078 0
minna.laitinen@fimnet.fi
Contact person for public queries
Name 37079 0
Mrs Minna Laitinen
Address 37079 0
Department of Orthopedics
Unit of Musculoskeletal Surgery
University Hospital Of Tampere
P.O.Box 2000
33521 Tampere
Country 37079 0
Finland
Phone 37079 0
+358405594598
Fax 37079 0
Email 37079 0
minna.laitinen@fimnet.fi
Contact person for scientific queries
Name 37080 0
Mrs Minna Laitinen
Address 37080 0
Department of Orthopedics
Unit of Musculoskeletal Surgery
University Hospital Of Tampere
P.O.Box 2000
33521 Tampere
Country 37080 0
Finland
Phone 37080 0
+358405594598
Fax 37080 0
Email 37080 0
minna.laitinen@fimnet.fi

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary