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

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
      • 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:

  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).

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
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

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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