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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000629730

Acronym

Accolade II-12

Enrollment

304

Registered

2013-06-03

Start date

2013-08-13

Completion date

2018-12-07

Last updated

2022-12-05

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

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1.Patient are male or non-pregnant females requiring a cementless THR for non-inflammatory degenerative joint disease of the hip. 2.Must be older than 18 years

Exclusion criteria

1. Patient has a cognitive impairment, an intellectual disability or a mental illness 2. People whose primary language is other than English 3. Pregnant Women 4. Children and or/young people (ie. <18 years)

Outcome results