Hip Fractures Treated With Uncemented Arthroplasties (HUA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Stockholm South General Hospital
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Christian Inngul, Stockholm South General Hospital
ClinicalTrials.gov Identifier:
NCT01798472
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Stockholm South General Hospital:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence


Other Outcome Measures:
  • General and surgical complications [ Time Frame: from operation until 12 month postoperatively ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 140
Study Start Date: November 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Femoral stem: Bimetric, Biomet
  • Femoral head: Biomet
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.
Other Names:
  • Femoral stem: Bimetric, Biomet
  • Acetabular cup, Maraton, DePuy
  • Bone cement, Optipac, Biomet
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.
Other Names:
  • Femoral stem, Exeter, Stryker
  • Unipolar femoral head, Stryker
  • Bone cement, Optipac, Biomet
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.
Other Names:
  • Femoral stem: Exeter, Stryker
  • Acetabular cup, Marathon, DePuy
  • Bone cement, Optipac, Biomet

Detailed 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798472

Contacts
Contact: Christian Inngul, MD 0046708355969 christian.inngul@sodersjukhuset.se

Locations
Sweden
Södersjukhuset (South general hospital), Department of orthopedic surgery Recruiting
Stockholm, Sweden, 118 83
Contact: Christian Inngul, M.D.    0046708355969    christian.inngul@sodersjukhuset.se   
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         
Sponsors and Collaborators
Stockholm South General Hospital
Karolinska Institutet
Investigators
Study Director: Sari Ponzer, M.D. Prof Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Christian Inngul, Consultant orthopeadic surgery, Stockholm South General Hospital
ClinicalTrials.gov Identifier: NCT01798472     History of Changes
Other Study ID Numbers: 2009/1188-31/1
Study First Received: February 19, 2013
Last Updated: February 21, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare

Keywords provided by Stockholm South General Hospital:
displaced femoral neck fractures
treatment
uncemented arthroplasty
cemented arthroplasty

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 29, 2014