- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399007
A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
April 3, 2018 updated by: Johnson & Johnson Medical (Suzhou) Ltd.
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.
Study Overview
Status
Completed
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 Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- The first affiliated hospital of Guangzhou Tranditional Meidical University
-
-
Hebei
-
Shijiazhuang, Hebei, China
- The third affiliated hospital of Hebei University
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- The second affiiliated hospital of Harbin Medical University
-
-
Jiangxi
-
Nanchang, Jiangxi, China
- The First Affiliated Hospital of Nanchang University
-
-
Ningxia
-
Yinchuan, Ningxia, China
- The affiliated hosoital of Ningxia Medical University
-
-
Xinjiang
-
Hohhot, Xinjiang, China
- The First Affiliated Hospital of Xinjiang Medicine University
-
-
Yunnan
-
Kunming, Yunnan, China
- The general hospital of Kunming
-
-
Zhejiang
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Hangzhou, Zhejiang, China
- The Second Affiliated Hospital of Zhejiang Medicine University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Total Hip System made in China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China
|
SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
|
Active Comparator: Total Hip System made outside of China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China
|
Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Harris Hip Total Score at 12 months postoperatively
Time Frame: 12 months postoperatively
|
12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
One year non-revision rate where revision is defined as removal of any component secondary to infection
Time Frame: 12 months postoperatively
|
12 months postoperatively
|
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
|
12 months postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harris Hip Total Score success: success is ≥ 80 points.
Time Frame: 12 months postoperatively
|
12 months postoperatively
|
|
Patient Reported Outcomes
Time Frame: Preoperation to 12 months postoperatively
|
SF 12: scores at 1 yr, change from pre-op.
WOMAC: scores at 1 yr., change from pre-op.
|
Preoperation to 12 months postoperatively
|
Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis
Time Frame: Preoperation to 12 months postoperatively
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Preoperation to 12 months postoperatively
|
|
Adverse Events: tally the type and frequency of adverse events
Time Frame: Preoperation to 12 months postoperatively
|
Preoperation to 12 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shigui Yan, The Second Affiliated Hospital of Zhejiang Medicine University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2015
Primary Completion (Actual)
December 4, 2017
Study Completion (Actual)
January 17, 2018
Study Registration Dates
First Submitted
March 20, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 26, 2015
Study Record Updates
Last Update Posted (Actual)
April 4, 2018
Last Update Submitted That Met QC Criteria
April 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPS-201301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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