A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement

DePuy Synthes

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis; Slipped Capital Femoral Epiphysis; Collagen Disorder; Congenital Hip Dysplasia; Avascular Necrosis; Nonunion of Femoral Fractures; Post-traumatic Arthritis; Traumatic Femoral Fractures

Treatments: Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished; Device: Ultima LX Collared Stem - Polished Finished; Device: Ultima LX Collarless Stem - Polished finished; Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished

Study type: Interventional

Funder types: Industry

Identifiers

NCT00208351

CT01/95

Details and patient eligibility

About

The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Enrollment: 164 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment

Exclusion criteria

i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 4 patient groups

1) Ultima LX Collared Stem - Non-Polished/Blasted Finished

Active Comparator group

Description:

A collared non-polished blasted finished cementless femoral component for use in total hip replacement.

Treatment:

Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished

2) Ultima LX Collared Stem - Polished Finished

Active Comparator group

Description:

A collared polished finished cementless femoral component for use in total hip replacement.

Treatment:

Device: Ultima LX Collared Stem - Polished Finished

3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished

Active Comparator group

Description:

A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.

Treatment:

Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished

4) Ultima LX Collarless Stem - Polished Finished

Active Comparator group

Description:

A collarless polished finished cementless femoral component for use in total hip replacement.

Treatment:

Device: Ultima LX Collarless Stem - Polished finished