Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures.
Hip fractures account for 20% of all fractures and displaced subcapital fractures represent 45% of the hip fracture workload. All of these patients are treated with some form of hip replacement. Recent randomised trials have confirmed that total hip replacement is probably the best choice of treatment in a fit older patient and is better than partial hip replacement or repair of the fracture with screws which are the other most commonly used treatments. Hip replacements may be cemented or uncemented. The uncemented type of hip replacement has not been commonly used in this group of patients but may have some advantages. The uncemented hip replacement is a shorter operation and this may be advantageous in the hip fracture population group since these are older patients, many of whom have other medical problems. The use of cement is occasionally associated with development of heart problems during anaesthesia. Participants: The original aim was to recruit 200 patients who have been admitted with a displaced subcapital hip fracture to the New Royal Infirmary and will undergo total hip replacement surgery within 48 hours of admission. Patients fitting the inclusion criteria will be given a patient information sheet and will be given between 24-48 hours to decide whether they give consent to participate in the trial. Patients who have given their consent will be randomly allocated to one of two groups i.e.. allocation to one of the two groups will entirely by chance. Each group will have 100 patients. Intervention Both groups will received a total hip replacement. The only difference between the two groups is the type of hip replacement and the way it is fixed in the thigh bone. One type of hip replacement requires cement ('Exeter'), the other ('CORAIL' from DePuy) doesn't. Other surgical protocols and care after the surgery will be exactly the same for both groups. Purpose The purpose of this research is to compare the clinical outcome (i.e. complications, revisions etc.) and the function of the patients between the two groups at several different time points: around 8 weeks, 4 months, 12 months and 24 months post surgery. Outcome measures Clinical: Surgery complications, duration of surgery, readmissions, revision surgery, duration of hospital stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.
NHS Lothian
Edinburgh, Edinburgh City, United Kingdom
Hip specific function
This was measured using the Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Time frame: 1 year
Hip specific function
Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.
Time frame: 6 and 72 months
Hip specific function
Harris Hip Score which ranges from 0 (worst score) to 100 (best score) points.
Time frame: 6, 12 and 72 months
Generic health
Euro Qol 5-dimension scale (3L) which ranges from -0.594 to 1, where 1 represents perfect health and 0 represents death. Negative values represent a state perceived as worse than death.
Time frame: 6, 12 and 72 months
Mobility
Timed get up and go test
Time frame: 6 months
Subjective patient hip pain
Pain visual analogue scale from 1 (no pain) to 10 (maximum pain)
Time frame: 6, 12 and 72 months
Operative time
Time from knife to skin to wound closure
Time frame: At time of index surgery
Intraoperative blood loss
Amount of blood lost during the index proceedure
Time frame: At time of of surgery
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Patient satisfaction
Overall how satisfied are you with the results of your hip replacement surgery?" The response to each question was recorded using a five-point Likert scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very dissatisfied.
Time frame: 6, 12 and 72 months
Complications
Rate of complications (intra / post operative)
Time frame: Time of surgery until one year following surgery
Survival
Kaplan Meier assessment of implant survival
Time frame: Time of index surgery until final follow up (72 months), revision or death