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

N

Nova Scotia Health Authority (NSHA)

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis

Treatments

Device: Cemented Endurance Stem
Device: Fully coated Prodigy stem

Study type

Interventional

Funder types

Other

Identifiers

NCT00689689
CDHA-RL-005

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

72+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

Fully Coated Prodigy Stem (AML)
Active Comparator group
Description:
Total hip arthroplasty with fully coated prodigy stem (AML)
Treatment:
Device: Fully coated Prodigy stem
Cemented Endurance Hip Stem
Active Comparator group
Description:
Total hip arthroplasty with cemented Endurance hip stem component
Treatment:
Device: Cemented Endurance Stem

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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