RecruitingACTRN12613000812796

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


Sponsor

Prof Donald Howie

Enrollment

300 participants

Start Date

Mar 24, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 67 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at how well total hip replacement holds up 7 to 10 years after the surgery. Researchers want to find out how much bone loss happens around the hip implant, how much the plastic lining wears down, and whether the cup moves over time. They also want to know how often the hip dislocates or causes instability problems. The study also compares two different sizes of the metal ball in the hip joint — a smaller 28 mm ball versus a larger 36 mm ball — to see if size makes a difference in long-term results. You may be eligible if: - You were previously enrolled in the related clinical trial ACTRN12609000678291 - You had a total hip replacement as part of that original trial - You are 67 years of age or older You may NOT be eligible if: - You were not part of the original hip replacement trial (ACTRN12609000678291) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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).


Locations(13)

The Royal Adelaide Hospital - Adelaide

NSW,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,SA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

NSW,SA,VIC, Australia

St John of God Hospital, Ballarat - Ballarat

NSW,SA,VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

NSW,SA,VIC, Australia

Maroondah Hospital - Ringwood East

NSW,SA,VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

NSW,SA,VIC, Australia

St Andrew's Hospital Inc - Adelaide

NSW,SA,VIC, Australia

Glenelg Community Hospital - Glenelg South

NSW,SA,VIC, Australia

Modbury Hospital - Modbury

NSW,SA,VIC, Australia

Whyalla Hospital - Whyalla

NSW,SA,VIC, Australia

England, United Kingdom

Scotland, United Kingdom

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ACTRN12613000812796