NCT00689689

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 16, 2012

Status Verified

May 1, 2008

Enrollment Period

11.3 years

First QC Date

May 30, 2008

Last Update Submit

February 15, 2012

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Revision

Secondary Outcomes (2)

  • Womac

  • SF-12

Study Arms (2)

Fully Coated Prodigy Stem (AML)

ACTIVE COMPARATOR

Total hip arthroplasty with fully coated prodigy stem (AML)

Device: Fully coated Prodigy stem

Cemented Endurance Hip Stem

ACTIVE COMPARATOR

Total hip arthroplasty with cemented Endurance hip stem component

Device: Cemented Endurance Stem

Interventions

Fully coated Prodigy stemDEVICE

Total hip arthroplasty with fully coated Prodigy stem

Fully Coated Prodigy Stem (AML)
Cemented Endurance StemDEVICE

total hip arthroplasty with cemented endurance stem

Cemented Endurance Hip Stem

Eligibility Criteria

Age72 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ross K Leighton, MD, FRCS(C)

    Capital Health, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

July 1, 1998

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 16, 2012

Record last verified: 2008-05

Locations

CA(1)