NexGen TM Tibia Clinical Outcomes Study

NCT03272373 | Completed Results FDA Device

• 1 other identifier: K.CR.I.G.16.34
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Radiograph Assessment of Progressive Tibial Radiolucencies

  Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of \>0.5mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.

  2 years

Secondary Outcomes (2)

• Oxford Knee Score

  2 years

• Revision Rate

  2 years

Study Arms (2)

Monoblock

OTHER

Subjects that receive the NexGen TM Monoblock Tibia

Device: NexGen TM Monoblock Tibia

Modular

OTHER

Subjects that receive the NexGen TM Modular Tibia

Device: NexGen TM Modular Tibia

Interventions

NexGen TM Monoblock Tibia DEVICE

Primary cementless tibia total knee arthroplasty

Monoblock

NexGen TM Modular Tibia DEVICE

Primary cementless tibia total knee arthroplasty

Modular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years of age.
• 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:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
• Patient has participated in the study-related Informed Consent process.
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
• Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.

You may not qualify if:

• Previous history of infection in the affected joint.
• Active local or systemic infection that may affect the prosthetic joint.
• Insufficient bone stock on femoral or tibial surfaces.
• Skeletal immaturity.
• Neuropathic arthropathy.
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
• A stable, painless arthrodesis in a satisfactory functional position.
• Severe instability secondary to the absence of collateral ligament integrity.
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
• Patient is currently participating in any other surgical intervention studies or pain management studies.
• Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (7)

LA BioMed at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Cornerstone Orthopaedics & Sports Medicine, P.C.

Wheat Ridge, Colorado, 80033, United States

Location

Franciscan Health

Mooresville, Indiana, 46158, United States

Location

Henry County Orthopedics and Sports Medicine

New Castle, Indiana, 47362, United States

Location

Woods Mill Orthopedics, Ltd

Chesterfield, Missouri, 63017, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Zimmer Biomet

clinicaloperations@zimmerbiomet.com

800-613-6131

Study Officials

• Kacy Arnold, RN, MBA

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 single arms being analyzed separately

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: October 3, 2017
• Primary Completion: March 30, 2023
• Study Completion: March 31, 2023
• Last Updated: December 30, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)