Clinical trial NCT04372966: Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures
Official title: Prospective, Double Blind Randomised Controlled Trial Comparing the Uncemented (CORAIL, DePuy) Versus Cemented (Exeter) Total Knee Arthroplasty for Displaced Subcapital Hip Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2020-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomaised controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients over the age of 60 years with a displaced intracapsular hip fracture and are admitted to the study centre and are under the care of four orthopaedic trauma surgeons
* patients who were independently mobile before their hip fracture
* patients without cognitive impairment (mini-mental score \>6) and able to give informed consent
* patients without serious concomitant disease

Exclusion Criteria:

* those not meeting the inclusion criteria
* patients who are not independently mobile outside the home
* unable to give informed consent
* serious concomitant disease with anaesthetic risk too great for Tsurgery

Primary outcomes:
measure: Hip specific function
timeFrame: 1 year
Secondary outcomes:
measure: Hip specific function
timeFrame: 6 and 72 months
measure: Hip specific function
timeFrame: 6, 12 and 72 months
measure: Generic health
timeFrame: 6, 12 and 72 months
measure: Mobility
timeFrame: 6 months
measure: Subjective patient hip pain
timeFrame: 6, 12 and 72 months
measure: Operative time
timeFrame: At time of index surgery
measure: Intraoperative blood loss
timeFrame: At time of of surgery
measure: Patient satisfaction
timeFrame: 6, 12 and 72 months
measure: Complications
timeFrame: Time of surgery until one year following surgery
measure: Survival
timeFrame: Time of index surgery until final follow up (72 months), revision or death
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
state: Edinburgh City
Study officials:
References: