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Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement

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Zimmer Biomet

Status

Terminated

Conditions

Osteoarthritis, Hip
Traumatic Arthritis of Hip

Treatments

Device: Answer® hip stem

Study type

Interventional

Funder types

Industry

Identifiers

NCT00588861
101-U-011

Details and patient eligibility

About

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.

Full description

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.

Enrollment

400 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Exclusion criteria

  • Infection, sepsis, and osteomyelitis

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

Answer® hip stem with Simplex Cement
Active Comparator group
Description:
Femoral stem replacement with Answer® hip stem \& Simplex Bone Cement
Treatment:
Device: Answer® hip stem
Device: Answer® hip stem
Answer® hip stem with Palacos Cement
Active Comparator group
Description:
Femoral stem replacement with Answer® hip stem \& Palacos Bone Cement
Treatment:
Device: Answer® hip stem
Device: Answer® hip stem

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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