Hip Fractures Treated With Uncemented Arthroplasties (HUA)

January 15, 2015 updated by: Christian Inngul, Stockholm South General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 118 83
        • Recruiting
        • Södersjukhuset (South general hospital), Department of orthopedic surgery
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Bone cement, Optipac, Biomet
  • Femoral stem: Bimetric, Biomet
  • Acetabular cup, Maraton, DePuy
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:
  • Bone cement, Optipac, Biomet
  • Femoral stem: Exeter, Stryker
  • Acetabular cup, Marathon, DePuy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month
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
12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from operation until 12 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stockholm South General Hospital

Collaborators

Karolinska Institutet

Investigators

  • Study Director: Sari Ponzer, M.D. Prof, Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/1188-31/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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