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NexGen TM Tibia Clinical Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272373
Recruitment Status : Active, not recruiting
First Posted : September 5, 2017
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE September 5, 2017
Last Update Posted Date October 27, 2021
Actual Study Start Date  ICMJE October 3, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
Radiographic Parameters [ Time Frame: 2 years ]
Radiograph assessments
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2017)
  • Oxford Knee Score [ Time Frame: 2 years ]
    The Oxford Knee Score assesses function and pain after total knee arthroplasty.
  • Revision Rate [ Time Frame: 2 years ]
    Rate of the number of revisions for any reason
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NexGen TM Tibia Clinical Outcomes Study
Official Title  ICMJE NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
Brief Summary The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
Detailed Description

This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device, and adverse event data. This clinical study will include the NexGen TM Monoblock Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.

The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.

The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.

The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:

  • No revisions for any reason
  • Oxford Knee Score >38
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2 single arms being analyzed separately
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Polyarthritis
  • Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle
  • Post-traumatic Loss of Joint Configuration
  • Moderate Valgus, Varus, or Flexion Deformities
Intervention  ICMJE
  • Device: NexGen TM Monoblock Tibia
    Primary cementless tibia total knee arthroplasty
  • Device: NexGen TM Modular Tibia
    Primary cementless tibia total knee arthroplasty
Study Arms  ICMJE
  • Monoblock
    Subjects that receive the NexGen TM Monoblock Tibia
    Intervention: Device: NexGen TM Monoblock Tibia
  • Modular
    Subjects that receive the NexGen TM Modular Tibia
    Intervention: Device: NexGen TM Modular Tibia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2017)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is at least 18 years of age.
  2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

    1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
    2. Collagen disorders and/or avascular necrosis of the femoral condyle.
    3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
    4. Moderate valgus, varus, or flexion deformities.
    5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
  3. Patient has participated in the study-related Informed Consent process.
  4. Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
  5. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
  6. Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.

Exclusion Criteria:

  1. Previous history of infection in the affected joint.
  2. Active local or systemic infection that may affect the prosthetic joint.
  3. Insufficient bone stock on femoral or tibial surfaces.
  4. Skeletal immaturity.
  5. Neuropathic arthropathy.
  6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
  7. A stable, painless arthrodesis in a satisfactory functional position.
  8. Severe instability secondary to the absence of collateral ligament integrity.
  9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
  10. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
  11. Patient is currently participating in any other surgical intervention studies or pain management studies.
  12. Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
  13. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03272373
Other Study ID Numbers  ICMJE K.CR.I.G.16.34
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP