CompletedPhase 4ACTRN12613000629730

A prospective, multi-centre randomised comparative study of implant fit, clinical outcomes and satisfaction with the Stryker Accolade II Hip Stem compared to the Corail Hip Stem


Sponsor

Stryker Australia Pty Ltd

Enrollment

250 participants

Start Date

Aug 13, 2013

Study Type

Interventional

Conditions

Summary

This study is a prospective, multi-centre, randomised clinical study comparing the preoperative radiographic plan to the intra-operative femoral stem sizing, and assessing post-operative fit, clinical and satisfaction outcomes. The study will be conducted in patients with Non-inflammatory Degenerative Joint Disease. In addition, a substudy is running in NZ to evaluate the differences in peri-prosthetic bone remodelling post hip replacement in 3 different femoral component implants. The Lunar iDXA (GE Healthcare, Madison, WI) densitometer is a Food and Drug Administration (FDA) - approved device for measuring BMD and body composition. The relationship between bone loss, patient functional outcome and implant survival across the 3 femoral stems will also be investigated.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • Patient are male or non-pregnant females requiring a cementless THR for non-inflammatory degenerative joint disease of the hip.
  • Must be older than 18 years

Exclusion Criteria4

  • Patient has a cognitive impairment, an intellectual disability or a mental illness
  • People whose primary language is other than English
  • Pregnant Women
  • Children and or/young people (ie. <18 years)

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Interventions

Patients randomised to this group will recieve an Accolade II Hip Stem. Duration of surgery is approximately 1.5hours.

Patients randomised to this group will recieve an Accolade II Hip Stem. Duration of surgery is approximately 1.5hours.


Locations(1)

Canterbury, New Zealand

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ACTRN12613000629730