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A Randomised Clinical trial of Pain and mobility folllowing Cemented vs Uncemented Hemiarthroplasty in elderly patients with hip fracture.

A Randomised Clinical trial of Pain and mobility folllowing Cemented vs Uncemented Hemiarthroplasty in elderly patients with displaced subcapital neck of femur fracture.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000367246
Enrollment
160
Registered
2009-05-27
Start date
2006-05-15
Completion date
2008-11-27
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Hip fracture is a very common presentation to hospital. The patient group is elderly and is associated with a long hospital stay often requiring extensive rehabilitation. Many of these patients suffer significant pain and disability following fracture and as a consequence of this are unable to return to their previous residence incurring significant cost increase associated with a higher level of care. This study has the potential to improve the outcome of these patients, reduce costly time in hospital and the requirement for further care following discharge related to reduced mobility. If either cemented or uncemented hemiarthroplasty is shown to improve pain control and increase mobility this will significantly improve outcome for these patients.

Interventions

Cemented hemiarthroplasty. This operation is to be performed through a Rorabeck Modification of the Hardinge Approach. The conjoined tendon of Vastus Lateralis and Gluteus removed in continuity with the capsule from anterior of Gt. Trochanter. An anterior superior capsulotomy is then performed with an incision directly along the line of the Femoral neck. Cementing is to be performed with second generation technique including Simplex cement with antibiotic mixed in a bowl and poured into inserti

Cemented hemiarthroplasty. This operation is to be performed through a Rorabeck Modification of the Hardinge Approach. The conjoined tendon of Vastus Lateralis and Gluteus removed in continuity with the capsule from anterior of Gt. Trochanter. An anterior superior capsulotomy is then performed with an incision directly along the line of the Femoral neck. Cementing is to be performed with second generation technique including Simplex cement with antibiotic mixed in a bowl and poured into insertion gun. Lavage and cement plug should be inserted prior. The cement shopuld be inserted retrograde and major pressurization avoided. Anteversion should be camparable to native anteversion and offset measured from digital xray prior to surgery. The stem insertion amount should also be measured prior to procedure during the templating process. This intervention takes approximately one hour of surgical time

Sponsors

ACC
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

All patients presenting to Auckland Hospital requiring hemiarthroplasty will be offered entry into the trial.

Exclusion criteria

Severe systemic disease recognized by the admitting team causing the patient to be unsuitable for the use of cement during the procedure.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026