Back to resultsA Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement
Primary Purpose
Osteoarthritis, Post-traumatic Arthritis, Collagen Disorder
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultima LX Collared Stem - Non-Polished/Blasted Finished
Ultima LX Collared Stem - Polished Finished
Ultima LX Collarless Stem - Non-Polished/Blasted Finished
Ultima LX Collarless Stem - Polished finished
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cemented
Eligibility Criteria
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
Sites / Locations
- Epsom General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1) Ultima LX Collared Stem - Non-Polished/Blasted Finished
2) Ultima LX Collared Stem - Polished Finished
3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished
4) Ultima LX Collarless Stem - Polished Finished
Arm Description
A collared non-polished blasted finished cementless femoral component for use in total hip replacement.
A collared polished finished cementless femoral component for use in total hip replacement.
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
A collarless polished finished cementless femoral component for use in total hip replacement.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00208351
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
The final assessments were conducted late and in a reduced format due to resource limitations at the site.
Study Start Date
May 1997 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-traumatic Arthritis, Collagen Disorder, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
Keywords
Hip, Cemented
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1) Ultima LX Collared Stem - Non-Polished/Blasted Finished
Arm Type
Active Comparator
Arm Description
A collared non-polished blasted finished cementless femoral component for use in total hip replacement.
Arm Title
2) Ultima LX Collared Stem - Polished Finished
Arm Type
Active Comparator
Arm Description
A collared polished finished cementless femoral component for use in total hip replacement.
Arm Title
3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished
Arm Type
Active Comparator
Arm Description
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
Arm Title
4) Ultima LX Collarless Stem - Polished Finished
Arm Type
Active Comparator
Arm Description
A collarless polished finished cementless femoral component for use in total hip replacement.
Intervention Type
Device
Intervention Name(s)
Ultima LX Collared Stem - Non-Polished/Blasted Finished
Intervention Description
A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
Intervention Type
Device
Intervention Name(s)
Ultima LX Collared Stem - Polished Finished
Intervention Description
A collared polished finished cementless femoral component for use in total hip replacement.
Intervention Type
Device
Intervention Name(s)
Ultima LX Collarless Stem - Non-Polished/Blasted Finished
Intervention Description
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
Intervention Type
Device
Intervention Name(s)
Ultima LX Collarless Stem - Polished finished
Intervention Description
A collarless polished finished cementless femoral component for use in total hip replacement.
Primary Outcome Measure Information:
Title
Stem movement measured radiographically at 2 years
Description
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.
Time Frame
2yrs post-surgery
Secondary Outcome Measure Information:
Title
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.
Description
The following outcome measures were used; VAS Pain score, SF36 Patient reported outcome, Satisfaction, Limb Length physical examination, and stem movement measured radiographically.
Time Frame
5yrs post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Epsom General Hospital
City
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24474088
Citation
Hutt J, Hazlerigg A, Aneel A, Epie G, Dabis H, Twyman R, Cobb A. The effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs. Int Orthop. 2014 Jun;38(6):1131-7. doi: 10.1007/s00264-013-2256-z. Epub 2014 Jan 29.
Results Reference
result
Learn more about this trial
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
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