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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. Identifier: NCT03272373
Recruitment Status : Active, not recruiting
First Posted : September 5, 2017
Last Update Posted : October 27, 2021
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
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 Device: NexGen TM Monoblock Tibia Device: NexGen TM Modular Tibia Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 single arms being analyzed separately
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Subjects that receive the NexGen TM Monoblock Tibia
Device: NexGen TM Monoblock Tibia
Primary cementless tibia total knee arthroplasty

Subjects that receive the NexGen TM Modular Tibia
Device: NexGen TM Modular Tibia
Primary cementless tibia total knee arthroplasty

Primary Outcome Measures :
  1. Radiographic Parameters [ Time Frame: 2 years ]
    Radiograph assessments

Secondary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 2 years ]
    The Oxford Knee Score assesses function and pain after total knee arthroplasty.

  2. Revision Rate [ Time Frame: 2 years ]
    Rate of the number of revisions for any reason

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03272373

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United States, California
LA BioMed at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
Cornerstone Orthopaedics & Sports Medicine, P.C.
Wheat Ridge, Colorado, United States, 80033
United States, Indiana
Franciscan Health
Mooresville, Indiana, United States, 46158
Henry County Orthopedics and Sports Medicine
New Castle, Indiana, United States, 47362
United States, Missouri
Woods Mill Orthopedics, Ltd
Chesterfield, Missouri, United States, 63017
United States, North Carolina
Pinehurst Surgical Clinic
Pinehurst, North Carolina, United States, 28374
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Zimmer Biomet
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Study Director: Kacy Arnold, RN, MBA Zimmer Biomet
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Responsible Party: Zimmer Biomet Identifier: NCT03272373    
Other Study ID Numbers: K.CR.I.G.16.34
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Pathologic Processes