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ACTIVE NOT RECRUITING

JOURNEY II XR Safety and Effectiveness PMCF

NCT03136887 · View on ClinicalTrials.gov ↗

Study Summary

This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

Interventions

  • DEVICE JOURNEY II XR Total Knee System

Study Locations (14)

New York

  • NYU Hospital for Joint Diseases / NYU Langone Medical Center — New York
  • Hospital for Special Surgery — New York
  • Columbia University Center for Hip & Knee Replacement — New York

Illinois

  • Castle Orthopaedics & Sports Medicine, S.C. — Aurora
  • Midwest Orthopaedics at Rush — Chicago

California

  • Loma Linda University Dept. of Orthopaedic Surgery — Loma Linda

Florida

  • Holy Cross Orthopedic Institute — Fort Lauderdale

Maryland

  • Anne Arundel Medical Center — Annapolis

Michigan

  • DeClaire LaMacchia Orthopaedic Institute — Rochester

Nevada

  • Reno Orthopaedic Center — Reno

New Jersey

  • Mercer Bucks Orthopaedics — Hamilton

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2017-07-28
Est. Completion 2029-04

Sponsor

Smith & Nephew

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03136887

The ClinicalTrials.gov registry entry for NCT03136887 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Smith & Nephew, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which JOURNEY II XR Total Knee System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03136887 reports 14 study locations spanning 11 distinct geographic areas — top geographies include New York, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03136887 about?

NCT03136887 is a clinical study titled "JOURNEY II XR Safety and Effectiveness PMCF". This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.

What is the current status of trial NCT03136887?

This trial is currently active not recruiting. The enrollment target is 176 participants. The study started on 2017-07-28. Estimated completion is 2029-04.

What conditions does trial NCT03136887 study?

This clinical trial studies the following conditions: Knee Osteoarthritis, Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee, Degenerative Arthritis Peripheral Joint, Failed Osteotomies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03136887?

The interventions under investigation include: JOURNEY II XR Total Knee System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03136887?

This trial is sponsored by Smith & Nephew, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03136887 being conducted?

This trial has 14 study locations across California, Florida, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial