Regenerex Tibial Tray Multi-Center Data Collection

October 25, 2021 updated by: Zimmer Biomet
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.

Study Overview

Status

Completed

Conditions

Detailed Description

See Protocol

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University, Department of Orthopedics
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Midwest Orthopedics at RUSH University
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Physicians Clinic of Iowa
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Health System
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Jordan-Young Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients

Description

Inclusion Criteria:

The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These indications are stated below:

  1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
  2. Correction of varus, valgus, or posttraumatic deformity.
  3. Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

  1. Ability and willingness of the patient to follow instructions, including control of weight and activity level
  2. A good nutritional state of the patient, and
  3. The patient must have reached full skeletal maturity

Exclusion Criteria:

The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are stated below:

  • Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.

  • Relative contraindications include:

    1. Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
    2. Osteoporosis,
    3. Metabolic disorders which may impair bone formation,
    4. Osteomalacia,
    5. Distant foci of infections which may spread to the implant site,
    6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
    7. Vascular insufficiency, muscular atrophy, neuromuscular disease,
    8. Incomplete or deficient soft tissue surrounding the knee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society Score
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survivorship
Time Frame: 5 years/ patient
5 years/ patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Jing Xie, PhD, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.ROWG2 (US 25)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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