Rheumatoid ArthritisPhase 4NCT01635166
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
A Phase 4 study testing Delta Motion in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 3 sites in 2 countries.
Trial summary
The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- Delta Motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2012to 8 Feb 2018
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged between 18 and 70 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.
- Subjects who are currently involved in any injury litigation claims.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
India2 sites
Apollo Speciality hospital, 320 Anna Salai
Chennai, 600035
All India Institute of Medical Sciences, Ansari nagar, South Extension
New Dehli, 110029
About this study
Official title: A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the DeltaMotion Cup System in Subjects Requiring a Total Hip Replacement
The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis, Traumatic Femoral Fractures, Congenital Hip Dysplasia
- Being tested
- Delta Motion
- Keywords
- Arthroplasty, Replacement, Hip, Cementless, Ceramic on Ceramic
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta MotionDevice
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.
| Study group | Role | What they receive |
|---|---|---|
| Delta Motion | Other | A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement Receives: Device: Delta Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier survivorship
To determine survivorship of the DeltaMotion Cup System at 3 years
Measured: 3 years
Secondary outcomes (6)
Kaplan-Meier survivorship
To determine survivorship of the DeltaMotion Cup System at 10 years
Measured: 10yrs post-surgery
Harris Hip Score
Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion.
Measured: 10yrs post-surgery
Oxford Hip Score
Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery.
Measured: 10yrs post-surgery
University of California Los Angeles (UCLA) Score
Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement
Measured: 10yrs post-surgery
Western Ontario and McMaster Universities (WOMAC) Score
Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee
Measured: 10yrs post-surgery
Radiological analysis
- Acetabular Migration (vertical or horizontal) less than 5mm
- Acetabular Migration (varus or valgus) less than 5 degrees
- No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones.
Measured: 10yrs post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study start1 Jul 2012
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635166
- Sponsor's protocol ID
- CT11/01
- Status last verified
- Jul 2018
- First submitted
- 6 Feb 2012
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the DeltaMotion Cup System in Subjects Requiring a Total Hip Replacement
- ClinicalTrials.gov ID
- NCT01635166
- Acronym / sponsor ID
- CT11/01
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis, Traumatic Femoral Fractures, Congenital Hip Dysplasia
- Keywords
- Arthroplasty, Replacement, Hip, Cementless, Ceramic on Ceramic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 9 Jul 2012 (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 monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delta Motion | Other | Device: Delta MotionA cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, aged between 18 and 70 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use
Key exclusion criteria (5 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.
- Subjects who are currently involved in any injury litigation claims.
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 |
|---|---|---|
| Delta MotionA cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement. | Device | Delta Motion |
Primary outcome
Kaplan-Meier survivorship
Time frame: 3 years
To determine survivorship of the DeltaMotion Cup System at 3 years
6 secondary outcomes
Kaplan-Meier survivorship
Time frame: 10yrs post-surgery
Harris Hip Score
Time frame: 10yrs post-surgery
Oxford Hip Score
Time frame: 10yrs post-surgery
University of California Los Angeles (UCLA) Score
Time frame: 10yrs post-surgery
Western Ontario and McMaster Universities (WOMAC) Score
Time frame: 10yrs post-surgery
Radiological analysis
Time frame: 10yrs post-surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Delta Motion in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 3 sites in 2 countries.
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 4 inclusion and 5 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. 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?
Kaplan-Meier survivorship (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2018.