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Arthritis, RheumatoidNCT02399046

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

A study testing Total Knee System made in China (Sigama, CoCr, PFC) and Total Knee System made outside of China (Sigama, NP, PFC) in people with Arthritis, Rheumatoid and Osteoarthritis, run by Johnson & Johnson Medical (Suzhou) Ltd. at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Total Knee System made in China (Sigama, CoCr, PFC) and Total Knee System made outside of China (Sigama, NP, PFC)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
9 sitesChina
Study dates
17 Aug 2017to 25 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . The subject is ≥18years old
  • . The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
  • . Subject is a suitable candidate for cemented primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
  • . Subject must meet all criteria specified in BOTH China Knee stem and P.F.C.® Sigma knee instructions for use (IFU)
  • . 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).
  • . Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
  • . 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.
  • . 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.

Who cannot join

  • Subject does not provide written voluntary consent to participate in the clinical study.
  • The Subject is a woman who is pregnant or lactating.
  • Subject is anticipated to require a contralateral TKA between 6 months and 1 year.
  • Contralateral knee has already been enrolled in this study.
  • Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
  • 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.
Show all 20Show fewer
  • 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
  • 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).
  • Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
  • Subject has a medical condition with less than 2 years of life expectancy.
  • 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.
  • The Subject is currently participating in another investigational drug or device study.
  • Subject is a prisoner.
  • The Subject has a known allergy to any implant components (metal for example).
  • Hemoglobin < 11 g/dL
  • Albumin < 90% normal low limit
  • CRP > 2 times normal upper limit
  • ESR > 2 times normal upper limit
  • Subjects who have abnormal coagulation exam results and cannot be corrected by drugs or plasma replacement
  • -

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • The West China Hospital of Sichuan University

    Chengdu, Sichuan

  • General Hospital of Guangzhou Military Command of PLA

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Xijing Hospital

    Xi’an, Shanxi

  • The affiliated hosoital of Ningxia Medical University

    Yinchuan, Ningxia

Other trials in China

About this study

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

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

Read the 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.

Being tested
Total Knee System made in China (Sigama, CoCr, PFC), Total Knee System made outside of China (Sigama, NP, PFC)
Medical subject headings
Arthritis, Rheumatoid, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee System made in China (Sigama, CoCr, PFC)Device

    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)Device

    SIGAMA PS CEM FEM; PFC MOD TIB TRAY NP; SIGAMA STAB XLK INS; PFC SIGAMA/RD/DOME PAT

Study groups in NCT02399046
Study groupRoleWhat they receive
Total Knee System made in ChinaExperimentalPatinet in this arm will be implanted with Primary Total Knee Arthroplasty Devices Manufactured in China
Receives: Device: Total Knee System made in China (Sigama, CoCr, PFC)
Total Knee System made outside of ChinaActive comparatorPatient in this arm will be implanted with Primary Total Knee Arthroplasty Devices Manufactured Outside of China
Receives: Device: Total Knee System made outside of China (Sigama, NP, PFC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12-month post-op AKS

    Measured: 12 months postoperatively

Secondary outcomes (6)

  1. Non-revision rates(revision for any reason) through the end of the study

    Measured: 12 months postoperatively

  2. One year non-revision rate where revision is defined as removal of any component secondary to infection

    Measured: 12 months postoperatively

  3. 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

    Measured: 12 months postoperatively

  4. 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.

    Measured: Preoperation to12 months postoperatively

  5. WOMAC scores at the 1-year follow-up interval

    Measured: Preoperation to12 months postoperatively

  6. 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.

    Measured: Preoperation to12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2015 (estimated)
  2. Study start17 Aug 2017
  3. Primary completion10 Jul 2019
  4. Study completion25 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399046
Sponsor's protocol ID
DPS-201302
Status last verified
Nov 2019
First submitted
20 Mar 2015
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Total Knee System made in China (Sigama, CoCr, PFC) and Total Knee System made outside of China (Sigama, NP, PFC) in people with Arthritis, Rheumatoid and Osteoarthritis, run by Johnson & Johnson Medical (Suzhou) Ltd. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month post-op AKS (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02399046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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