Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00689689
Enrollment
48
Registered
2008-06-04
Start date
1998-07-31
Completion date
2009-11-30
Last updated
2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DEVICEFully coated Prodigy stem

Total hip arthroplasty with fully coated Prodigy stem

DEVICECemented Endurance Stem

total hip arthroplasty with cemented endurance stem

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
72 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Revision

Secondary

MeasureTime frame
Womac
SF-12

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026