Hip Fractures Treated With Uncemented Arthroplasties

Femoral Neck Fractures Clinical Trial

— HUA  

Official title:

Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01798472
• Other study ID #: 2009/1188-31/1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 19, 2013
• Last updated: January 15, 2015
• Start date: November 2009
• Est. completion date: November 2018

Study information

• Verified date: January 2015
• Source: Stockholm South General Hospital
• Contact: Christian Inngul, MD
• Phone: 0046708355969
• Email: christian.inngul[@]sodersjukhuset.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.

The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.

Description:

Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction.

Mortality and morbidity varies between undisplaced and displaced femoral neck fractures.

Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws.

The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries.

Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• displaced fracture of the femoral neck

• independent living

• independent ambulation (with or without walking aids)

Exclusion Criteria:

• pathological fracture

• severe dementia (defined as =3 in short portable mental questionnaire) preoperatively

• preexisting ipsilateral hip disease

• neurological disease (e.g. M. Parkinson)

• psychiatric disease which makes understanding or following instructions impossible

• history of drug and alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• cemented hemiarthroplasty
Patients aged 80 years and older operated with an cemented hemiarthroplasty. Fixation of the wedge-shaped, polished ChromCobalt steel femoral stem to host bone by use of PolyMetylMetAcrylat bone cement. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.
• reverse hybrid total hip arthroplasty
Patients aged 65 to 79 years operated with an uncemented femoral component combined with cemented acetabular cup. The femoral stem is fixed to the host bone by press-fit technique. We use a tapered, proximally hydroxyapatite coated, titanium stem. The acetabular cup is fixed to the host bone with bone cement. We use an all-polyethylene design. Bone cement consists of PolyMetylMetAcrylat.
• cemented total hip arthroplasty
Patients aged 65 to 79 years operated with a cemented femoral stem combined with a cemented acetabular cup. Femoral and acetabular component are fixed to the host bone by use of bone cement. The femoral stem is a polished, wedge-shaped design made of ChromCobalt steel. The acetabular cup is fixed to the host bone with bone cement.The acetabular cup an all-polyethylene design. Bone cement consists of PolyMetAcrylat.
• uncemented hemiarthroplasty
Patients aged 80 years and older are randomized to uncemented hemiarthroplasty. Fixation of the tapered, proximally hydroxyapatite coated, titanium stem to the host bone by "press-fit"-technique. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.

Locations

Country	Name	City	State
Sweden	Södersjukhuset (South general hospital), Department of orthopedic surgery	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Stockholm South General Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General and surgical complications	general complications such as cardio-pulmonary events, pressure ulcer, pneumonia, deep vein thrombosis (DVT).; surgical complications such as infections, reoperations due to all causes, dislocations	from operation until 12 month postoperatively	No
Primary	Harris Hip Score	Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions: Pain, function, absence of deformity and range of motion	12 month	No
Secondary	Health related quality of life	We use the patient reported instrument EQ-5D. A questionnaire consisting of 5 questions to evaluate health related quality of life.	12 month	No
Secondary	Radiological follow up	Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence	12 month	Yes