A randomised, controlled trial assessing the effectiveness of the iliac suction device in improving socket fixation in primary hip arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07813343

Enrollment

Registered

2003-09-12

Start date

2002-08-30

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

Surgery: Primary hip arthroplasty Surgery

Interventions

Patients undergoing primary total hip replacement will be randomised at the time of surgery. They will undergo the gold standard Exeter hip replacement in the usual fashion. Half of the patients will

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged between 55 and 80 years old 2. Patients undergoing uncomplicated primary hip replacement Therapeutic research. 12 Patients in each arm of trial.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
The aim of the study is to perform a randomised controlled trial assessing the effectiveness of the iliac suction device in improving the bone-cement interface in primary total hip replacement. Outcome measures including complications, clinical scores, gross radiological appearances and also movement assessed by the technique of RSA. Study endpoints: Life Tables and Survival Curves with confidence limits for different definitions of failure including implant loosening and radiological evidence of failure including implant migration (as defined by RSA), excessive wear, radiolucencies etc. Log rank comparison.	—

Measure

Time frame

The aim of the study is to perform a randomised controlled trial assessing the effectiveness of the iliac suction device in improving the bone-cement interface in primary total hip replacement. Outcome measures including complications, clinical scores, gross radiological appearances and also movement assessed by the technique of RSA. Study endpoints: Life Tables and Survival Curves with confidence limits for different definitions of failure including implant loosening and radiological evidence of failure including implant migration (as defined by RSA), excessive wear, radiolucencies etc. Log rank comparison.

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Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026