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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Radiographic Evaluation to Compare a Polished and Non-polished Collared Stem and a Polished and Non Polished Collarless Stem in Primary Total Hip Replacement

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

Intervention / Treatment
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* Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished
* Device: Ultima LX Collared Stem - Polished Finished
* Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished
* Device: Ultima LX Collarless Stem - Polished finished


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1) Ultima LX Collared Stem - Non-Polished/Blasted Finished<br>A collared non-polished blasted finished cementless femoral component for use in total hip replacement. | Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished<br>* A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.<br>|
| Active Comparator: 2) Ultima LX Collared Stem - Polished Finished<br>A collared polished finished cementless femoral component for use in total hip replacement. | Device: Ultima LX Collared Stem - Polished Finished<br>* A collared polished finished cementless femoral component for use in total hip replacement.<br>|
| Active Comparator: 3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished<br>A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement. | Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished<br>* A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.<br>|
| Active Comparator: 4) Ultima LX Collarless Stem - Polished Finished<br>A collarless polished finished cementless femoral component for use in total hip replacement. | Device: Ultima LX Collarless Stem - Polished finished<br>* A collarless polished finished cementless femoral component for use in total hip replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem movement measured radiographically at 2 years | Stem movement was measured radiographically by comparing baseline stem position with the stem position 2 years after surgery. If migration was observed to be 5 or more mm, it was considered clinically significant migration. | 2yrs post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of Visual Analog Pain (VAS), 36-Item Short Form Health Survey (SF-36), Satisfaction, Limb Length and stem movement measured radiographically at 5 years. | The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically. | 5yrs post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Cemented