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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399007
• Other study ID #: DPS-201301
• Status: Completed
• Phase: N/A
• First received: March 20, 2015
• Last updated: April 3, 2018
• Start date: June 7, 2015
• Est. completion date: January 17, 2018

Study information

• Verified date: April 2018
• Source: Johnson & Johnson Medical (Suzhou) Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 17, 2018
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Avascular Necrosis
• Congenital Hip Dysplasia
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Rheumatoid Arthritis

Intervention

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)
• 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)

Locations

Country	Name	City	State
China	The first affiliated hospital of Guangzhou Tranditional Meidical University	Guangzhou	Guangdong
China	The second Affiliated Hospital of Zhejiang Medicine University	Hangzhou	Zhejiang
China	The second affiiliated hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital of Xinjiang Medicine University	Hohhot	Xinjiang
China	The general hospital of Kunming	Kunming	Yunnan
China	The first affiliated hospital of Nanchang University	Nanchang	Jiangxi
China	The third affiliated hospital of Hebei University	Shijiazhuang	Hebei
China	The affiliated hosoital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Medical (Suzhou) Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Harris Hip Total Score success: success is = 80 points.		12 months postoperatively
Other	Patient Reported Outcomes	SF 12: scores at 1 yr, change from pre-op. WOMAC: scores at 1 yr., change from pre-op.	Preoperation to 12 months postoperatively
Other	Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis		Preoperation to 12 months postoperatively
Other	Adverse Events: tally the type and frequency of adverse events		Preoperation to 12 months postoperatively
Primary	Harris Hip Total Score at 12 months postoperatively		12 months postoperatively
Secondary	One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection		12 months postoperatively
Secondary	One year non-revision rate where revision is defined as removal of any component secondary to infection		12 months postoperatively