OsteoarthritisPhase 3NCT00208351
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
A Phase 3 study testing Ultima LX Collared Stem - Non-Polished/Blasted Finished, Ultima LX Collared Stem - Polished Finished and Ultima LX Collarless Stem - Non-Polished/Blasted Finished in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorder
- What is being tested?
- Ultima LX Collared Stem - Non-Polished/Blasted Finished, Ultima LX Collared Stem - Polished Finished and Ultima LX Collarless Stem - Non-Polished/Blasted Finished
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 1997to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorder, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures
- Being tested
- 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
- Keywords
- Hip, Cemented
- Medical subject headings
- Osteoarthritis, Collagen Diseases, Osteonecrosis, Hip Dislocation, Congenital, Slipped Capital Femoral Epiphyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultima LX Collared Stem - Non-Polished/Blasted FinishedDevice
A collared non-polished/blasted finished cementless femoral component for use in total hip replacement.
Ultima LX Collared Stem - Polished FinishedDevice
A collared polished finished cementless femoral component for use in total hip replacement.
Ultima LX Collarless Stem - Non-Polished/Blasted FinishedDevice
A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement.
Ultima LX Collarless Stem - Polished finishedDevice
A collarless polished finished cementless femoral component for use in total hip replacement.
| Study group | Role | What they receive |
|---|---|---|
| 1) Ultima LX Collared Stem - Non-Polished/Blasted Finished | Active comparator | A collared non-polished blasted finished cementless femoral component for use in total hip replacement. Receives: Device: Ultima LX Collared Stem - Non-Polished/Blasted Finished |
| 2) Ultima LX Collared Stem - Polished Finished | Active comparator | A collared polished finished cementless femoral component for use in total hip replacement. Receives: Device: Ultima LX Collared Stem - Polished Finished |
| 3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished | Active comparator | A collarless non-polished/blasted finished cementless femoral component for use in total hip replacement. Receives: Device: Ultima LX Collarless Stem - Non-Polished/Blasted Finished |
| 4) Ultima LX Collarless Stem - Polished Finished | Active comparator | A collarless polished finished cementless femoral component for use in total hip replacement. Receives: Device: Ultima LX Collarless Stem - Polished finished |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2yrs post-surgery
Secondary outcomes (1)
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.
Measured: 5yrs post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 1997
- Primary completionNov 2004
- Study completionMar 2015
Why it stopped: The final assessments were conducted late and in a reduced format due to resource limitations at the site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208351
- Sponsor's protocol ID
- CT01/95
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24474088
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00208351
- Acronym / sponsor ID
- CT01/95
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorder, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures
- Keywords
- Hip, Cemented
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The final assessments were conducted late and in a reduced format due to resource limitations at the site.
- Enrolment
- 164 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- May 1997
- Primary completion
- Nov 2004 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1) Ultima LX Collared Stem - Non-Polished/Blasted Finished | Active comparator | Device: Ultima LX Collared Stem - Non-Polished/Blasted FinishedA collared non-polished blasted finished cementless femoral component for use in total hip replacement. |
| 2) Ultima LX Collared Stem - Polished Finished | Active comparator | Device: Ultima LX Collared Stem - Polished FinishedA collared polished finished cementless femoral component for use in total hip replacement. |
| 3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished | Active comparator | Device: Ultima LX Collarless Stem - Non-Polished/Blasted FinishedA collarless non-polished/blasted finished cementless femoral component for use in total hip replacement. |
| 4) Ultima LX Collarless Stem - Polished Finished | Active comparator | Device: Ultima LX Collarless Stem - Polished finishedA collarless polished finished cementless femoral component for use in total hip replacement. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultima LX Collared Stem - Non-Polished/Blasted FinishedA collared non-polished/blasted finished cementless femoral component for use in total hip replacement. | Device | 1) Ultima LX Collared Stem - Non-Polished/Blasted Finished |
| Ultima LX Collared Stem - Polished FinishedA collared polished finished cementless femoral component for use in total hip replacement. | Device | 2) Ultima LX Collared Stem - Polished Finished |
| Ultima LX Collarless Stem - Non-Polished/Blasted FinishedA collarless non-polished/blasted finished cementless femoral component for use in total hip replacement. | Device | 3) Ultima LX Collarless Stem - Non-Polished/Blasted Finished |
| Ultima LX Collarless Stem - Polished finishedA collarless polished finished cementless femoral component for use in total hip replacement. | Device | 4) Ultima LX Collarless Stem - Polished Finished |
Primary outcome
Stem movement measured radiographically at 2 years
Time frame: 2yrs post-surgery
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.
1 secondary outcome
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.
Time frame: 5yrs post-surgery
Results and safety
The study was stopped early (reason given: The final assessments were conducted late and in a reduced format due to resource limitations at the site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Results publication: PubMed 24474088Hutt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultima LX Collared Stem - Non-Polished/Blasted Finished, Ultima LX Collared Stem - Polished Finished and Ultima LX Collarless Stem - Non-Polished/Blasted Finished in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The final assessments were conducted late and in a reduced format due to resource limitations at the site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stem movement measured radiographically at 2 years (time frame: 2yrs post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.