A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements

NCT ID: NCT00689689

Last Updated: 2012-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fully Coated Prodigy Stem (AML)

Total hip arthroplasty with fully coated prodigy stem (AML)

Group Type ACTIVE_COMPARATOR

Fully coated Prodigy stem

Intervention Type DEVICE

Total hip arthroplasty with fully coated Prodigy stem

Cemented Endurance Hip Stem

Total hip arthroplasty with cemented Endurance hip stem component

Group Type ACTIVE_COMPARATOR

Cemented Endurance Stem

Intervention Type DEVICE

total hip arthroplasty with cemented endurance stem

Interventions

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Fully coated Prodigy stem

Total hip arthroplasty with fully coated Prodigy stem

Intervention Type DEVICE

Cemented Endurance Stem

total hip arthroplasty with cemented endurance stem

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
* Revisions of failed osteotomies may be included
* Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients \> 72 years of age

Exclusion Criteria

* Patients with active infection
* Revision cemented total hip replacement
* Charcot joints
* Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
* C.D.H. with abnormally placed acetabuli or femoral canals
* Fibromyalgia patients
Minimum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ross K Leighton, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Capital Health, Canada

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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CDHA-RL-005

Identifier Type: -

Identifier Source: org_study_id

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