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Hip Fractures Treated With Uncemented Arthroplasties (HUA)

Primary Purpose

Femoral Neck Fractures

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
cemented hemiarthroplasty
reverse hybrid total hip arthroplasty
cemented total hip arthroplasty
uncemented hemiarthroplasty
Sponsored by
Stockholm South General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring displaced femoral neck fractures, treatment, uncemented arthroplasty, cemented arthroplasty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Södersjukhuset (South general hospital), Department of orthopedic surgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

uncemented hemiarthroplasty

reverse hybrid total hip arthroplasty

cemented hemiarthroplasty

cemented total hip arthroplasty

Arm Description

Patients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty

Patients aged between 65 and 79 years treated with an reverse hybrid arthroplasty.

Patients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty

Patients aged between 65 and 79 years treated with an cemented total hip arthroplasty.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Radiological follow up
Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence

Full Information

First Posted
February 19, 2013
Last Updated
January 15, 2015
Sponsor
Stockholm South General Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01798472
Brief Title
Hip Fractures Treated With Uncemented Arthroplasties
Acronym
HUA
Official Title
Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm South General Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
displaced femoral neck fractures, treatment, uncemented arthroplasty, cemented arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uncemented hemiarthroplasty
Arm Type
Experimental
Arm Description
Patients aged 80 or older with displaced femoral neck fracture treated with an uncemented hemiarthroplasty
Arm Title
reverse hybrid total hip arthroplasty
Arm Type
Experimental
Arm Description
Patients aged between 65 and 79 years treated with an reverse hybrid arthroplasty.
Arm Title
cemented hemiarthroplasty
Arm Type
Active Comparator
Arm Description
Patients aged 80 or older with displaced femoral neck fracture treated with an cemented hemiarthroplasty
Arm Title
cemented total hip arthroplasty
Arm Type
Active Comparator
Arm Description
Patients aged between 65 and 79 years treated with an cemented total hip arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
cemented hemiarthroplasty
Other Intervention Name(s)
Femoral stem, Exeter, Stryker, Unipolar femoral head, Stryker, Bone cement, Optipac, Biomet
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
reverse hybrid total hip arthroplasty
Other Intervention Name(s)
Femoral stem: Bimetric, Biomet, Acetabular cup, Maraton, DePuy, Bone cement, Optipac, Biomet
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
cemented total hip arthroplasty
Other Intervention Name(s)
Femoral stem: Exeter, Stryker, Acetabular cup, Marathon, DePuy, Bone cement, Optipac, Biomet
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
uncemented hemiarthroplasty
Other Intervention Name(s)
Femoral stem: Bimetric, Biomet, Femoral head: Biomet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Harris Hip Score
Description
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
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
We use the patient reported instrument EQ-5D. A questionnaire consisting of 5 questions to evaluate health related quality of life.
Time Frame
12 month
Title
Radiological follow up
Description
Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence
Time Frame
12 month
Other Pre-specified Outcome Measures:
Title
General and surgical complications
Description
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
Time Frame
from operation until 12 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Inngul, MD
Phone
0046708355969
Email
christian.inngul@sodersjukhuset.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sari Ponzer, M.D. Prof
Organizational Affiliation
Department of orthopedic surgery, South general hospital, Sjukhusbacken 10, 118 83 Stockholm, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Södersjukhuset (South general hospital), Department of orthopedic surgery
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Inngul, M.D.
Phone
0046708355969
Email
christian.inngul@sodersjukhuset.se
First Name & Middle Initial & Last Name & Degree
Christian Inngul, M.D.
First Name & Middle Initial & Last Name & Degree
Anders Enocson, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Richard Blomfeldt, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Sari Ponzer, M.D. Prof

12. IPD Sharing Statement

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Hip Fractures Treated With Uncemented Arthroplasties

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