A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
Primary Purpose
Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)
Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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).
Sites / Locations
- The first affiliated hospital of Guangzhou Tranditional Meidical University
- The third affiliated hospital of Hebei University
- The second affiiliated hospital of Harbin Medical University
- The first affiliated hospital of Nanchang University
- The affiliated hosoital of Ningxia Medical University
- The First Affiliated Hospital of Xinjiang Medicine University
- The general hospital of Kunming
- The second Affiliated Hospital of Zhejiang Medicine University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Total Hip System made in China
Total Hip System made outside of China
Arm Description
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China
Outcomes
Primary Outcome Measures
Harris Hip Total Score at 12 months postoperatively
Secondary Outcome Measures
One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
One year non-revision rate where revision is defined as removal of any component secondary to infection
Full Information
NCT ID
NCT02399007
First Posted
March 20, 2015
Last Updated
April 3, 2018
Sponsor
Johnson & Johnson Medical (Suzhou) Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02399007
Brief Title
A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 7, 2015 (Actual)
Primary Completion Date
December 4, 2017 (Actual)
Study Completion Date
January 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Medical (Suzhou) Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total Hip System made in China
Arm Type
Experimental
Arm Description
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China
Arm Title
Total Hip System made outside of China
Arm Type
Active Comparator
Arm Description
Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China
Intervention Type
Device
Intervention Name(s)
Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)
Intervention Description
SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
Intervention Type
Device
Intervention Name(s)
Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)
Intervention Description
Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
Primary Outcome Measure Information:
Title
Harris Hip Total Score at 12 months postoperatively
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
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
Title
One year non-revision rate where revision is defined as removal of any component secondary to infection
Time Frame
12 months postoperatively
Other Pre-specified Outcome Measures:
Title
Harris Hip Total Score success: success is ≥ 80 points.
Time Frame
12 months postoperatively
Title
Patient Reported Outcomes
Description
SF 12: scores at 1 yr, change from pre-op. WOMAC: scores at 1 yr., change from pre-op.
Time Frame
Preoperation to 12 months postoperatively
Title
Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis
Time Frame
Preoperation to 12 months postoperatively
Title
Adverse Events: tally the type and frequency of adverse events
Time Frame
Preoperation to 12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigui Yan
Organizational Affiliation
The second Affiliated Hospital of Zhejiang Medicine University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of Guangzhou Tranditional Meidical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The third affiliated hospital of Hebei University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The second affiiliated hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
The first affiliated hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The affiliated hosoital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medicine University
City
Hohhot
State/Province
Xinjiang
Country
China
Facility Name
The general hospital of Kunming
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The second Affiliated Hospital of Zhejiang Medicine University
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China
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