Outcomes 7 to 10 years following total hip replacement

Dislocation, osteolysis, polyethylene wear, acetabular component migration and other complications 7 to 10 years following randomisation to either a large 36 mm or standard 28 mm diameter metal on highly cross-linked polyethylene articulation in total hip replacement

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000812796

Enrollment

300

Registered

2013-07-24

Start date

2010-03-24

Completion date

2014-06-15

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

At 7-10 years after total hip replacement, this study will determine the incidence of bone loss around a primary total hip prosthesis with a metal head and polyethylene liner, as determined by CT, as well as the wear of the polyethylene and the movement of the acetabular cup, as determined by plain radiographs. The study will also examine the incidence of dislocation and other symptoms of hip instability, as well as the reasons for revision or re-operation. In addition, the study will show if there are any differences in these outcomes between prostheses with standard 28 mm and large 36 mm femoral heads.

Interventions

The current study is a 7 to 10 year follow-up study of patients enrolled in the randomised controlled trial described in ACTRN12609000678291. Patients undergoing total hip replacement were randomised to receive either a large 36 mm articulation (intervention) or standard 28 mm articulation (control).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

67 Years to No maximum

Healthy volunteers

Inclusion criteria

Only patients involved in the RCT, ACTRN12609000678291, will be eligible for this study

Exclusion criteria

Not previously enrolled in the RCT, ACTRN12609000678291

Outcome results