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

Osteoarthritis Clinical Trial

Official title:

A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Knee Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399046
• Other study ID #: DPS-201302
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: October 25, 2019

Study information

• Verified date: November 2019
• Source: Johnson & Johnson Medical (Suzhou) Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Knee Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 25, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. . The subject is =18years 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 cemented primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.

4. . Subject must meet all criteria specified in BOTH China Knee stem and P.F.C.® Sigma knee 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 knee replacement or, if a contralateral knee replacement is anticipated, the surgery must occur within 6 months of the first study knee TKA. The second knee 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. Subject is anticipated to require a contralateral TKA between 6 months and 1 year.

4. Contralateral knee has already been enrolled in this study.

5. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.

6. 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.

7. Subjects with severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor in bone surrounding knee joint that, in the opinion of the investigator, will negatively impact implant fixation and the outcome of the investigation

8. 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).

9. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.

10. Subject has a medical condition with less than 2 years of life expectancy.

11. The Subject has comorbid condition(s) that could limit the Subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.

12. The Subject is currently participating in another investigational drug or device study.

13. Subject is a prisoner.

14. The Subject has a known allergy to any implant components (metal for example).

15. Hemoglobin < 11 g/dL

16. Albumin < 90% normal low limit

17. CRP > 2 times normal upper limit

18. ESR > 2 times normal upper limit

19. Subjects who have abnormal coagulation exam results and cannot be corrected by drugs or plasma replacement

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Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Joint Diseases
• Osteoarthritis
• Post-traumatic; Arthrosis

Intervention

Device:
• Total Knee System made in China (Sigama, CoCr, PFC)
SIGAMA PS FEMUR; TIB tray Cem Cocr; SIGAMA STAB XLK INS; PFC SIG ROUND DOME PAT 3PEG
• Total Knee System made outside of China (Sigama, NP, PFC)
SIGAMA PS CEM FEM; PFC MOD TIB TRAY NP; SIGAMA STAB XLK INS; PFC SIGAMA/RD/DOME PAT

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xiangya Hospital Central South University	Changsha	Hunan
China	The West China Hospital of Sichuan University	Chengdu	Sichuan
China	General Hospital of Guangzhou Military Command of PLA	Guangzhou	Guangdong
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	The First Teaching Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Xijing Hospital	Xi'an	Shanxi
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	The proportion of Composite Successes in each treatment group will be assessed at the 1year follow-up interval		12 months postoperatively
Other	Blood samplets will be collected and data will be summarized		pre-operative and immediate post-operatively
Primary	12-month post-op AKS		12 months postoperatively
Secondary	Non-revision rates(revision for any reason) through the end of the study		12 months postoperatively
Secondary	One year non-revision rate where revision is defined as removal of any component secondary to infection		12 months postoperatively
Secondary	American Knee Society Total Score success (where success is defined as a score of 80 points or higher)at the 1 year follow-up inerval		12 months postoperatively
Secondary	Short-form 12(SF-12) general health questionnaire each of 8 dimensions and the overall Physical and Mental health domains, at 1-year follow-up interval.		Preoperation to12 months postoperatively
Secondary	WOMAC scores at the 1-year follow-up interval		Preoperation to12 months postoperatively
Secondary	Radiogrphic assessment of clinically relevant radiolucent line(RLL)and osteolysis,migration and subsidence, by comparing the 3 month post-operative x-ray to the 1 year follow up x-ray inerval.		Preoperation to12 months postoperatively