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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Fully coated Prodigy stem; Device: Cemented Endurance Stem

• Registration Number: NCT00689689
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-07
• Status Verified: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-04
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fully Coated Prodigy Stem (AML)	Fully coated Prodigy stem	Total hip arthroplasty with fully coated prodigy stem (AML)
Cemented Endurance Hip Stem	Cemented Endurance Stem	Total hip arthroplasty with cemented Endurance hip stem component

Primary Outcome Measures

Name	Time	Method
Revision

Secondary Outcome Measures

Name	Time	Method
Womac
SF-12

Trial Locations

Locations (1)

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada