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Trial record 62 of 3329 for:    China Medicine University Hospital

A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02399007
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Medical (Suzhou) Ltd.

Brief Summary:
A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Congenital Hip Dysplasia Avascular Necrosis Device: Total Hip System made in China (SUN, CoCr, Duraloc, Marathon) Device: Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : June 7, 2015
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : January 17, 2018

Resource links provided by the National Library of Medicine


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
Device: 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)

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
Device: 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)




Primary Outcome Measures :
  1. Harris Hip Total Score at 12 months postoperatively [ Time Frame: 12 months postoperatively ]

Secondary Outcome Measures :
  1. 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 ]
  2. One year non-revision rate where revision is defined as removal of any component secondary to infection [ Time Frame: 12 months postoperatively ]

Other Outcome Measures:
  1. Harris Hip Total Score success: success is ≥ 80 points. [ Time Frame: 12 months postoperatively ]
  2. 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.

  3. Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis [ Time Frame: Preoperation to 12 months postoperatively ]
  4. Adverse Events: tally the type and frequency of adverse events [ Time Frame: Preoperation to 12 months postoperatively ]


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is ≥55, and ≤80 years old
  2. The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
  3. Subject is a suitable candidate for primary total hip replacement using the devices described in this CIP
  4. Subject must meet all criteria specified in BOTH SUN hip stem and Summit hip stem instructions for use (IFU)
  5. 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).
  6. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  7. 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.
  8. 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:

  1. Subject does not provide written voluntary consent to participate in the clinical study.
  2. The Subject is a woman who is pregnant or lactating.
  3. Subjects who have undergone THA in contralateral hip within the past 6 months.
  4. Contralateral hip has been enrolled in the study.
  5. Presence of any previous prosthetic hip replacement device in affected hip.
  6. Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the affected hip
  7. Subject has hip dysplasia CROWE classification grade of 3 or 4.
  8. Above knee amputation of either contralateral or ipsilateral leg
  9. Subject is anticipated to require a contralateral THA between 6 months and 1-year.
  10. Subject has an active infection
  11. 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.
  12. 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;
  13. 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).
  14. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  15. Subject has a medical condition with less than 2 years of life expectancy due to other medical conditions.
  16. 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.
  17. The patient is currently participating in another investigational drug or device study.
  18. Subject is a prisoner.
  19. Subject has a known allergy to any component of the implant (metal for example).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399007


Locations
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China, Guangdong
The first affiliated hospital of Guangzhou Tranditional Meidical University
Guangzhou, Guangdong, China
China, Hebei
The third affiliated hospital of Hebei University
Shijiazhuang, Hebei, China
China, Heilongjiang
The second affiiliated hospital of Harbin Medical University
Harbin, Heilongjiang, China
China, Jiangxi
The first affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
China, Ningxia
The affiliated hosoital of Ningxia Medical University
Yinchuan, Ningxia, China
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medicine University
Hohhot, Xinjiang, China
China, Yunnan
The general hospital of Kunming
Kunming, Yunnan, China
China, Zhejiang
The second Affiliated Hospital of Zhejiang Medicine University
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Johnson & Johnson Medical (Suzhou) Ltd.
Investigators
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Principal Investigator: Shigui Yan The second Affiliated Hospital of Zhejiang Medicine University

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Responsible Party: Johnson & Johnson Medical (Suzhou) Ltd.
ClinicalTrials.gov Identifier: NCT02399007     History of Changes
Other Study ID Numbers: DPS-201301
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Necrosis
Hip Dislocation
Hip Dislocation, Congenital
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Joint Dislocations
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities