Clinical trial NCT02399007: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Congenital Hip Dysplasia
Avascular Necrosis
Lead sponsor: Johnson & Johnson Medical (Suzhou) Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 160
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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).

Primary outcomes:
measure: Harris Hip Total Score at 12 months postoperatively
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection
timeFrame: 12 months postoperatively
measure: One year non-revision rate where revision is defined as removal of any component secondary to infection
timeFrame: 12 months postoperatively
Other outcomes:
measure: Harris Hip Total Score success: success is ≥ 80 points.
timeFrame: 12 months postoperatively
measure: Patient Reported Outcomes
timeFrame: Preoperation to 12 months postoperatively
measure: Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis
timeFrame: Preoperation to 12 months postoperatively
measure: Adverse Events: tally the type and frequency of adverse events
timeFrame: Preoperation to 12 months postoperatively
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou Tranditional Meidical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The third affiliated hospital of Hebei University
state: Hebei
city: Harbin
country: China
facility: The second affiiliated hospital of Harbin Medical University
state: Heilongjiang
city: Nanchang
country: China
facility: The first affiliated hospital of Nanchang University
state: Jiangxi
city: Yinchuan
country: China
facility: The affiliated hosoital of Ningxia Medical University
state: Ningxia
city: Hohhot
country: China
facility: The First Affiliated Hospital of Xinjiang Medicine University
state: Xinjiang
city: Kunming
country: China
facility: The general hospital of Kunming
state: Yunnan
city: Hangzhou
country: China
facility: The second Affiliated Hospital of Zhejiang Medicine University
state: Zhejiang
Study officials:
affiliation: The second Affiliated Hospital of Zhejiang Medicine University
name: Shigui Yan
role: PRINCIPAL_INVESTIGATOR
References: