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

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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Osteoarthritis; Post-traumatic; Arthrosis
• Intervention / Treatment: Device: Total Knee System made in China (Sigama, CoCr, PFC); Device: Total Knee System made outside of China (Sigama, NP, PFC)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • General Hospital of Guangzhou Military Command of PLA
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
  • Ningxia
    • Yinchuan, Ningxia, China
      • The affiliated hosoital of Ningxia Medical University
  • Shandong
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Qingdao University
  • Shanxi
    • Xi'an, Shanxi, China
      • Xijing Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • The West China Hospital of Sichuan University
  • Xinjiang
    • Urumqi, Xinjiang, China
      • The First Teaching Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total Knee System made in China; Patinet in this arm will be implanted with Primary Total Knee Arthroplasty Devices Manufactured in China	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
Active Comparator: Total Knee System made outside of China; Patient in this arm will be implanted with Primary Total Knee Arthroplasty Devices Manufactured Outside of China	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
12-month post-op AKS	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-revision rates(revision for any reason) through the end of the study	12 months postoperatively
One year non-revision rate where revision is defined as removal of any component secondary to infection	12 months postoperatively
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
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
WOMAC scores at the 1-year follow-up interval	Preoperation to12 months postoperatively
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

Other Outcome Measures

Outcome Measure	Time Frame
The proportion of Composite Successes in each treatment group will be assessed at the 1year follow-up interval	12 months postoperatively
Blood samplets will be collected and data will be summarized	pre-operative and immediate post-operatively

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical (Suzhou) Ltd.
• Investigators: Principal Investigator: Fuxing Pei, The West China Hospital of Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): October 25, 2019

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): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis
• Other Study ID Numbers: DPS-201302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No