NCT02139345

Brief Summary

This is a prospective, randomized, multicenter clinical study to compare the safety and efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 23, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2016

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

May 7, 2014

Last Update Submit

November 13, 2017

Conditions

Primary OsteoarthritisRheumatoid ArthritisPost-traumatic ArthritisAvascular Necrosis

Keywords

OsteoarthritisRheumatoid arthritisPost-traumatic arthritisAvascular necrosisAVN

Outcome Measures

Primary Outcomes (1)

  • The Original Knee Society Clinical Score (KSCS)

    The Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. For the results, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.

    1 year post-operative

Secondary Outcomes (6)

  • The Original Knee Society Functional Score (KSFS)

    1 year post-operative

  • Revision for any reason

    Up to 1 year post-operative

  • Linear radiolucencies and radiographic abnormalities

    Up to 1 year post-operative

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    1 year post-operative

  • SF-12 Health Survey

    1 year post-operative

  • +1 more secondary outcomes

Study Arms (2)

TC-A PS

EXPERIMENTAL

Subject will be implanted with the TC-A PS Total Knee Replacement System

Device: TC-A PS Total Knee Replacement System

TC-PLUS Solution PS

ACTIVE COMPARATOR

Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System.

Device: TC-PLUS Solution PS Total Knee Replacement System

Interventions

TC-A PS Total Knee Replacement SystemDEVICE

Subject will be implanted with the TC-A PS Total Knee Replacement System

Also known as: TC-A PS
TC-A PS
TC-PLUS Solution PS Total Knee Replacement SystemDEVICE

Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System

Also known as: TC-PLUS Solution PS
TC-PLUS Solution PS

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, aged between 50 and 75 years inclusive of Chinese ethnicity.
  • Subject presents with primary osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or avascular necrosis of knee joint requiring primary total knee replacement with the PS knee system.
  • Subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an EC-approved consent form.
  • Subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
  • Life expectancy of subject is over 2 years.

You may not qualify if:

  • Bilateral knee disease with the anticipated need for bilateral knee implant during study participation (i.e., within the next 12 months).
  • Subject has known or suspected metal sensitivity.
  • Subject is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
  • Subject is severely obese (BMI\>35).
  • Subject has hip arthritis and/or replacement.
  • Subject had an active infection or sepsis (treated or untreated)
  • Subject has conditions that may compromise implant stability or postoperative recovery (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
  • Subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. mental illness, mental retardation).
  • Subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. For examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (AIDS).
  • Subject is a woman who is pregnant or lactating，or intends to become pregnant during the course of the study.
  • Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
  • Subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
  • Known alcohol and/or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nanjing First Hospital

Nanjing, Jiangsu, 100730, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 100035, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteonecrosisOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianhao Lin, Professor

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Investigator who assesses KSS score is blinded to the subject's treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subject was randomized to receive the treatment of investigational device or the comparator.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 15, 2014

Study Start

September 23, 2014

Primary Completion

November 23, 2016

Study Completion

November 23, 2016

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)