Hip Fractures Treated With Uncemented Arthroplasties (HUA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01798472|
Recruitment Status : Unknown
Verified January 2015 by Christian Inngul, Stockholm South General Hospital.
Recruitment status was: Recruiting
First Posted : February 25, 2013
Last Update Posted : January 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fractures||Procedure: cemented hemiarthroplasty Procedure: reverse hybrid total hip arthroplasty Procedure: cemented total hip arthroplasty Procedure: uncemented hemiarthroplasty||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2018|
Experimental: uncemented hemiarthroplasty
Patients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty
Procedure: 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.
Experimental: reverse hybrid total hip arthroplasty
Patients aged between 65 and 79 years treated with an reverse hybrid arthroplasty.
Procedure: 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.
Active Comparator: cemented hemiarthroplasty
Patients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty
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.
Active Comparator: cemented total hip arthroplasty
Patients aged between 65 and 79 years treated with an cemented total hip arthroplasty.
Procedure: 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.
- Harris Hip Score [ Time Frame: 12 month ]
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
- Health related quality of life [ Time Frame: 12 month ]We use the patient reported instrument EQ-5D. A questionnaire consisting of 5 questions to evaluate health related quality of life.
- Radiological follow up [ Time Frame: 12 month ]Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence
- General and surgical complications [ Time Frame: from operation until 12 month postoperatively ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798472
|Contact: Christian Inngul, MDfirstname.lastname@example.org|
|Södersjukhuset (South general hospital), Department of orthopedic surgery||Recruiting|
|Stockholm, Sweden, 118 83|
|Contact: Christian Inngul, M.D. 0046708355969 email@example.com|
|Principal Investigator: Christian Inngul, M.D.|
|Sub-Investigator: Anders Enocson, M.D. Ph.D.|
|Sub-Investigator: Richard Blomfeldt, M.D. Ph.D.|
|Sub-Investigator: Sari Ponzer, M.D. Prof|
|Study Director:||Sari Ponzer, M.D. Prof||Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden|