Is a new type of socket joint of a hip prosthesis stable without the use of screws in patients undergoing total hip replacement?

Radiostereometric analysis of acetabular component migration following randomisation to either a non-holed tantalum trabecular metal-coated acetabular shell or a cluster-holed titanium fibre metal-coated acetabular shell fixed with one or two screws in patients with osteoarthritis scheduled to undergo primary total hip replacement through posterior a approach

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000882729

Enrollment

Registered

2013-08-07

Start date

2007-03-15

Completion date

2013-10-15

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

This randomised controlled trial aims to determine whether a tantalum trabecular metal acetabular component in a primary total hip replacement prosthesis can achieve adequate initial fixation without the use of screws. This study utilises radiostereometric analysis, the most sensitive radiographic technique available to measure acetabular component migration in vivo.

Interventions

Primary total hip replacement using a tantalum trabecular metal coated acetabular shell. This is a surgical procedure where the femoral head is removed and replaced by a 28 mm metal prosthetic femoral head, which is attached to a femoral stem inserted into the femur. The head then articulates with a plastic (highly cross-linked polyethylene) liner in a metal acetabular shell, which is inserted into the acetabulum. Initial stability of the shell is achieved by press-fit fixation, without the use of screws. The duration of the operation is between about 45 minutes and 4 hours, depending on the complexity of the operation. During the operation tiny tantalum beads are inserted into the periprosthetic bone to enable determination of acetabular component migration using a highly sophisticated radiographic technique, namely radiostereometric analysis.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

40 Years to 64 Years

Healthy volunteers

Inclusion criteria

1. undergoing primary total hip replacement through posterior approach 2. diagnosis of osteoarthritis 3. walking ability restricted only by hip pathology

Exclusion criteria

1. previous infection 2. inflammatory arthritis 3. Crowe-2 DDH or worse dysplasia 4. abnormal acetabulum 5. increased risk of osteopaenia

Outcome results