Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000773932
Ethics application status
Approved
Date submitted
21/07/2011
Date registered
22/07/2011
Date last updated
22/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does osteoarthritis of the hip make failure of internal fixation more likely? A comparison of all hip fractures, comparing the presence of osteoarthritis to rates of failure.
Scientific title
In patients who received a proximal femoral nail or dynamic hip screw in order to fixate their proximal femoral fracture, does the presence of osteoarthritis at time of fracture increase the likelihood of proximal femoral fracture fixation failure? An observational study of 3 tertiary hospitals in WA over the period January 2002 - December 2004
Secondary ID [1] 262641 0
Nil
Universal Trial Number (UTN)
U1111-1122-9775
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proximal femoral fractures 268356 0
Condition category
Condition code
Injuries and Accidents 268484 268484 0 0
Fractures
Musculoskeletal 268529 268529 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study- is osteoarthritis (OA) present at the time of hip fracture, identified by radiograph. Over a 4 year follow-up period for the patients included in the research, what proportion have failure of fixation for their hip fracture and what proportion of this group had OA at the time of the initial hip fracture.
Intervention code [1] 267016 0
Not applicable
Comparator / control treatment
This study will compare no OA at the time of hip fracture to OA at the time of hip fracture then compare these groups to see if there is a difference between rates of failure of fixation of the fracture over a 4 year follow-up.
Control group
Active

Outcomes
Primary outcome [1] 269269 0
The aim of this study is to determine whether a diagnosis of OA in the hip, makes failure of internal fixation in hip fractures more likely; in the patient population group undergoing internal fixation for proximal femoral fractures at any Western Australian tertiary hospital between 2002-2004.

Retrospective data will be collected using hospital medical records (operation reports) to identify all patients who sustained hip fractures requiring internal fixation, between January 1st 2002 to December 31st 2004, at the three tertiary hospitals in Western Australia- Royal Perth Hospital, Sir Charles Gardner Hospital and Fremantle Hospital. Hospital operation reports for hip fractures requiring internal fixation will be obtained through the medical records department at each tertiary hospital in Western Australia.

Internal fixation will be defined by the use of any intramedullary or extramedullary implant used for the treatment of a proximal femoral fracture.

Using the IMPAX imaging database, all patients identified who meet the inclusion criteria will have the radiographs identifying their fracture(s) reviewed. Evidence of OA at the time of fracture will be recorded. The Kellgren and Lawrence radiological assessment of osteoarthritis will be used to describe the radiological findings of OA. This method of assessment was chosen based on the study by Reijman et al. (2004) finding the Kellgren and Laurence grade to be a useful OA definition for epidemiological studies focusing on the presence of hip OA. A diagnosis of OA will be made when a grade of 2 or above is identified.

The Kellgren and Lawrence grading system (Reijman, et al., 2004)
Grade Description
0 No OA No osteoarthritis
1 Doubtful Possible narrowing of joint space medially and possible osteophytes around the femoral head; or osteophytes alone
2 Mild Definite narrowing of joint space inferiorly, definite osteophytes, and slight sclerosis
3 Moderate Marked narrowing of joint space, definite osteophytes, some sclerosis and cyst formation, and deformity of the femoral head and acetabulum
4 Severe Gross loss of joint space with sclerosis and cysts, marked deformity of femoral head and acetabulum and large osteophytes
Hips classified as grade 2 or more were defined as having osteoarthritis

Patients identified will be followed up over a period of 4 years to determine if there was failure in hip fracture fixation. Failure of fixation will be determined through using the IMPAX imaging database. Failure will be determined by subsequent radiographs of the hip, taken after the initial fixation, identifying one or of more of the following: non-union, segmental collapse, implant failure, peri-prosthetic fracture, conversion to hemi- or total- arthroplasty. Successful fixation (no failure of fixation) will be determined by the absence of the above findings.

The IMPAX database- this database contains retrospective data on all patients across the metropolitan/outer urban area of Western Australia who have had radiological imaging investigation. The database will be accessed from Fremantle Hospital. User names and passwords are required in order to access the database and these will be supplied by Fremantle Hospital. The database contains patient information, imaging investigations and reporting on those imaging investigations. The information entered into IMPAX database comes from radiologist reports. Only patients who meet the criteria for inclusion into the study will have their information accessed.

Other patient factors that will be collected include: age, sex, fracture type (displaced or undisplaced) and the dates when the radiographs where taken to identify a proximal femoral facture and the dates when the radiographs where taken to identify failure of fixation.
Timepoint [1] 269269 0
Patient data collected from 1st January 2002- 31st December 2004. There will be a 4 year follow-up period to identify internal fixation failure.
Secondary outcome [1] 279249 0
Nil
Timepoint [1] 279249 0
Nil

Eligibility
Key inclusion criteria
Inclusion criteria- All patients who sustained hip fractures requiring internal fixation, between January 1st 2002 to December 31st, at the three tertiary hospitals in Western Australia- Royal Perth Hospital, Sir Charles Gardner Hospital and Fremantle Hospital.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria- Patients requiring hemiarthropasty or total hip arthroplasty; patients with other forms of arthritis such as rheumatoid arthritis or seronegative arthritis.

Study design
Purpose
Natural history
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4279 0
6959

Funding & Sponsors
Funding source category [1] 267500 0
Self funded/Unfunded
Name [1] 267500 0
Charles Gallagher
Country [1] 267500 0
Australia
Primary sponsor type
Individual
Name
Charles Gallagher
Address
St Thomas More College, Mounts Bay Rd, Crawely, WA, 6009
Country
Australia
Secondary sponsor category [1] 266544 0
None
Name [1] 266544 0
Nil
Address [1] 266544 0
Nil
Country [1] 266544 0
Other collaborator category [1] 252118 0
Individual
Name [1] 252118 0
Pier Yates
Address [1] 252118 0
Fremantle Hospital, Fremantle, WA, Australia, 6959
PO Box 480, Fremantle WA 6959, Australia
Country [1] 252118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269467 0
Human Research Ethics Committee- Notre Dame University, Fremantle, WA
Ethics committee address [1] 269467 0
19 Mouat St, Fremantle, WA, 6959
Ethics committee country [1] 269467 0
Australia
Date submitted for ethics approval [1] 269467 0
Approval date [1] 269467 0
19/05/2011
Ethics approval number [1] 269467 0
011038F

Summary
Brief summary
Aim: The aim of this study is to determine whether a diagnosis of osteoarthritis (OA) in the hip, makes failure of internal fixation in hip fractures more likely; in the patient population group undergoing internal fixation for proximal femoral fractures at any Western Australian tertiary hospital between 2002-2004.

Importance: Hip fractures are very common in Australia and are associated with high mortality and morbidity. The number of hip fractures in Australian women is projected to increase from 11 300 per year in 1996 to 44 700 in 2051; In men, the number is projected to rise from 4 000 to 15 300. The cost of this clinical problem is estimated at between 0.9-1.4% of the total government healthcare expenditure. Most will be managed with surgery, through internal fixation. This process can fail (failure of internal fixation). Many of the patient factors behind failure of fixation are unknown. Through clinical observation it is assumed that OA does increase the likelihood of fixation failure, however no published research exists to support this assumption. The reasons behind why OA may have this effect relates to alterations in bone homeostasis. Given that OA is highly prevalent in our society it is important to determine if a link exists between hip OA and failure of fixation. If a link is established, this information would assist clinicians in the choice of an appropriate fixation technique and reduce the likelihood of failure and therefore reoperation. This information would contribute to an improved efficiency of health care provision in this patient group. In addition, it would serve to use the limited health dollar more efficaciously.

Methods: This is a multi-centred study in which data will be collected retrospectively, investigating an estimated 700-800 patients records, across the three tertiary hospitals in Western Australia, where internal fixation was performed after hip fracture. This sample size will allow study estimates to be representative of the population estimate. The presence of OA at time of fracture will be identified. Failure of internal fixation will be identified over a four year follow-up period. The collected data will be analysed using a Proportional Hazard Regression model (Cox Regression model) to measure rates of failure of fixation between two patient groups: the patient group with no hip OA and the patient group with hip OA.

Benefits: The median cost for hospital treated proximal femoral fractures is approximately $15,984 per fracture. Reducing the number of fixation failures would therefore result in measurable reductions to health care budget expenditure, in combination with the reduction in mortality and morbidity associated with reoperation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32887 0
Address 32887 0
Country 32887 0
Phone 32887 0
Fax 32887 0
Email 32887 0
Contact person for public queries
Name 16134 0
Charles Gallagher
Address 16134 0
St Thomas More College, Mounts Bay Rd, Crawely, WA, 6009
Country 16134 0
Australia
Phone 16134 0
+61 (0)409407456
Fax 16134 0
Email 16134 0
[email protected]
Contact person for scientific queries
Name 7062 0
Charles Gallagher
Address 7062 0
St Thomas More College, Mounts Bay Rd, Crawely, WA, 6009
Country 7062 0
Australia
Phone 7062 0
+61 (0)409407456
Fax 7062 0
Email 7062 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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