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NexGen TM Tibia Clinical Outcomes Study

NCT03272373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-12-30

Study results available
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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

Interventions

DEVICE

NexGen TM Monoblock Tibia

Primary cementless tibia total knee arthroplasty

DEVICE

NexGen TM Modular Tibia

Primary cementless tibia total knee arthroplasty

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Kacy Arnold, RN, MBA · Zimmer Biomet

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2023-03-30
Completion
2023-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272373 on ClinicalTrials.gov