Rheumatoid ArthritisNCT02399007
A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
A study testing Total Hip System made in China (SUN, CoCr, Duraloc, Marathon) and Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon) in people with Rheumatoid Arthritis and Congenital Hip Dysplasia, run by Johnson & Johnson Medical (Suzhou) Ltd. at 8 sites in China.
Trial summary
A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis
- What is being tested?
- Total Hip System made in China (SUN, CoCr, Duraloc, Marathon) and Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 8 sitesChina
- Study dates
- 7 Jun 2015to 17 Jan 2018
- Phase
- Interventional
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is ≥55, and ≤80 years old
- The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
- Subject is a suitable candidate for primary total hip replacement using the devices described in this CIP
- Subject must meet all criteria specified in BOTH SUN hip stem and Summit hip stem instructions for use (IFU)
- Before surgery, subject is willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB).
- Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
- Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the patient reported outcomes (PROs) in the CIP.
- Subject is receiving a unilateral hip replacement or, if a contralateral hip replacement is anticipated, the surgery must occur within 6 months of the first study hip. The second hip will not be enrolled in the study.
Who cannot join
- Subject does not provide written voluntary consent to participate in the clinical study.
- The Subject is a woman who is pregnant or lactating.
- Subjects who have undergone THA in contralateral hip within the past 6 months.
- Contralateral hip has been enrolled in the study.
- Presence of any previous prosthetic hip replacement device in affected hip.
- Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the affected hip
Show all 19Show fewer
- Subject has hip dysplasia CROWE classification grade of 3 or 4.
- Above knee amputation of either contralateral or ipsilateral leg
- Subject is anticipated to require a contralateral THA between 6 months and 1-year.
- Subject has an active infection
- Subject has a malignant disease, severe condition, alcohol or drug addiction and/or mental disorders that the investigator believes will interfere with the study participation.
- Subjects with severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor in the bone surrounding the hip joint that, in the opinion of the investigator, will negatively impact implant fixation and the outcome of the investigation;
- Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease).
- Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
- Subject has a medical condition with less than 2 years of life expectancy due to other medical conditions.
- The patient has comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- The patient is currently participating in another investigational drug or device study.
- Subject is a prisoner.
- Subject has a known allergy to any component of the implant (metal for example).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The first affiliated hospital of Guangzhou Tranditional Meidical University
Guangzhou, Guangdong
The second Affiliated Hospital of Zhejiang Medicine University
Hangzhou, Zhejiang
The second affiiliated hospital of Harbin Medical University
Harbin, Heilongjiang
The First Affiliated Hospital of Xinjiang Medicine University
Hohhot, Xinjiang
The general hospital of Kunming
Kunming, Yunnan
The first affiliated hospital of Nanchang University
Nanchang, Jiangxi
The third affiliated hospital of Hebei University
Shijiazhuang, Hebei
The affiliated hosoital of Ningxia Medical University
Yinchuan, Ningxia
About this study
Official title: A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China
A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.
Read the detailed description
A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of China
- Being tested
- Total Hip System made in China (SUN, CoCr, Duraloc, Marathon), Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
- Medical subject headings
- Arthritis, Rheumatoid, Hip Dislocation, Congenital, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)Device
SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)Device
Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
| Study group | Role | What they receive |
|---|---|---|
| Total Hip System made in China | Experimental | Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China Receives: Device: Total Hip System made in China (SUN, CoCr, Duraloc, Marathon) |
| Total Hip System made outside of China | Active comparator | Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China Receives: Device: Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Total Score at 12 months postoperatively
Measured: 12 months postoperatively
Secondary outcomes (2)
One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
Measured: 12 months postoperatively
One year non-revision rate where revision is defined as removal of any component secondary to infection
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start7 Jun 2015
- Primary completion4 Dec 2017
- Study completion17 Jan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigui Yan, Principal investigator, The second Affiliated Hospital of Zhejiang Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399007
- Sponsor's protocol ID
- DPS-201301
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China
- ClinicalTrials.gov ID
- NCT02399007
- Acronym / sponsor ID
- DPS-201301
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2015 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 26 Mar 2015 (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.
A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.
Detailed description
A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Hip Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of China
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip System made in China | Experimental | Device: Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China |
| Total Hip System made outside of China | Active comparator | Device: Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is ≥55, and ≤80 years old
- The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
- Subject is a suitable candidate for primary total hip replacement using the devices described in this CIP
- Subject must meet all criteria specified in BOTH SUN hip stem and Summit hip stem instructions for use (IFU)
- Before surgery, subject is willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB).
Key exclusion criteria (19 listed)
- Subject does not provide written voluntary consent to participate in the clinical study.
- The Subject is a woman who is pregnant or lactating.
- Subjects who have undergone THA in contralateral hip within the past 6 months.
- Contralateral hip has been enrolled in the study.
- Presence of any previous prosthetic hip replacement device in affected hip.
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 |
|---|---|---|
| Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO) | Device | Total Hip System made in China |
| Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO) | Device | Total Hip System made outside of China |
Primary outcome
Harris Hip Total Score at 12 months postoperatively
Time frame: 12 months postoperatively
2 secondary outcomes
One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
Time frame: 12 months postoperatively
One year non-revision rate where revision is defined as removal of any component secondary to infection
Time frame: 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Shigui Yan principal investigator
The second Affiliated Hospital of Zhejiang Medicine University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip System made in China (SUN, CoCr, Duraloc, Marathon) and Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon) in people with Rheumatoid Arthritis and Congenital Hip Dysplasia, run by Johnson & Johnson Medical (Suzhou) Ltd. at 8 sites in China.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Harris Hip Total Score at 12 months postoperatively (time frame: 12 months postoperatively). 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 4 Apr 2018.