Randomized Control Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients With Displaced Hip Fractures - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00556842

Purpose

The purpose of this study is to observe patients over 50 years of age who have sustained a displaced femoral neck fracture, what the rate of revision surgery at 24 months when a total hip arthroplasty versus hemi-arthroplasty is used as the surgical treatment.

Condition	Intervention
Hip Fractures Femoral Neck Fractures	Procedure: Total Hip Arthroplasty Procedure: Hemi-Arthroplasty

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Hip Fracture Evaluation With ALternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients With Displaced Femoral Neck Fractures

Further study details as provided by McMaster University:

Primary Outcome Measures:

Revision surgery rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HRQOL (SF-12, WOMAC, EQ-5D) [ Time Frame: 2 and 10 weeks, 6,9,12,18 and 24 months ] [ Designated as safety issue: No ]
Complications (mortality, dislocation, infection, femoral fracture, deep venous thrombosis, and prosthesis loosening) [ Time Frame: 2 and 10 weeks, 6,9,12,18 and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Total Hip Arthroplasty	Procedure: Total Hip Arthroplasty Proscribed approaches will include minimally invasive THA (i.e., two incision approaches) and hinged prostheses or capture cups. To optimize feasibility and applicability of results, we will otherwise not standardize the surgical approach, the use of cemented components, the implant manufacturer, or femoral head size. Surgeons will use the manufacturer specific implant guides and jigs for insertion of the THA.
2: Active Comparator Hemi-Arthroplasty	Procedure: Hemi-Arthroplasty Surgeons will use modern implants for HA excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. We will not standardize the choice of modular unipolar versus bipolar HA. We will not standardize whether implants are inserted with cement or with a press-fit design.

Arms

Assigned Interventions

1: Active Comparator

Total Hip Arthroplasty

Procedure: Total Hip Arthroplasty

Proscribed approaches will include minimally invasive THA (i.e., two incision approaches) and hinged prostheses or capture cups. To optimize feasibility and applicability of results, we will otherwise not standardize the surgical approach, the use of cemented components, the implant manufacturer, or femoral head size. Surgeons will use the manufacturer specific implant guides and jigs for insertion of the THA.

2: Active Comparator

Hemi-Arthroplasty

Procedure: Hemi-Arthroplasty

Surgeons will use modern implants for HA excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. We will not standardize the choice of modular unipolar versus bipolar HA. We will not standardize whether implants are inserted with cement or with a press-fit design.

Detailed Description:

Annually, 36000 Canadians suffer hip fractures. Hip fractures are associated with a 30% mortality rate and impairment of independence and quality of life. Hemi-arthroplasty (HA) advocates note reduced rates of dislocation, DVTs, operating times, blood loss, and a technically less demanding procedure. Total hip arthroplasty (THA) advocates perceive benefits in improved patient function and quality of life. Methodological limitations of previous studies have not resolved the optimal operative approach.

We propose a multi-centre (5 Ontario sites), concealed 'expertise-based' randomized trial design wherein patients (N=100) are allocated to surgeons with either THA expertise or HA expertise. Our objective is to assess the feasibility of conducting a large definitive trial investigating the revision surgery rate and quality of life when THA versus HA is performed, in patients over 50+ years of age with a displaced femoral neck fracture.

We will monitor critical aspects of peri-operative care and rehabilitation for protocol deviations at regular intervals, up to 1-year post-surgery. We will independently adjudicate revision surgery rates. We will also assess patients for functional health and quality of life outcomes (SF-12, WOMAC, EQ-5D). We hypothesize that THA will have similar or lower revision surgery rates and higher functional outcome scores at 1-year compared with HA.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult men or women aged 50 years or greater.
Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs.
Displaced fractures in the judgment of the attending surgeon.
Operative treatment planned within 72 hours of presenting to the emergency room.
Patient was able to get about independently prior to the fracture.
Anticipated medical optimization for arthroplasty of the hip.
Provision of informed consent by patient or legal guardian.
Low energy fracture (defined as a fall from standing height), with no other trauma.
Assurance that surgeons with expertise in both THA and HA are available to perform surgery

Exclusion Criteria:

Patient not suitable for HA (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures, or severe osteoarthritis of the hip.
Associated injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
Retained hardware around the affected hip.
Infection around the hip (soft tissue or bone).
Patients with a disorder of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
Moderate or severe cognitively impaired patients (Six Item Screener with ≥3 errors).
Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
Enrolment of patient in another ongoing drug or surgical intervention trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556842

Contacts

Contact: Helena Viveiros, BSc BA	905-527-4322 ext 44696	viveiro@mcmaster.ca
Contact: Sheila Sprague, MSc	905-527-4322 ext 44490	sprags@mcmaster.ca

Locations

Netherlands
Erasmus Medical Center	Recruiting
Rotterdam, Netherlands, 3000 CA

Sponsors and Collaborators

Hamilton Health Sciences

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Principal Investigator:

Mohit Bhandari, MD FRCSC MSc

McMaster University

More Information

International Hip Fracture Research Collaborative This link exits the ClinicalTrials.gov site

Responsible Party:	ZonMw ( Henk J Smid, directeur )
Study ID Numbers:	HE-001
Study First Received:	November 9, 2007
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00556842
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

hip fracture
femoral neck fractures
hemiarthroplasty
total hip arthroplasty

Study placed in the following topic categories:

Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Quality of Life
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Hip Injuries

ClinicalTrials.gov processed this record on January 15, 2009