Regenerex Tibial Tray Multi-Center Data Collection

NCT ID: NCT00859963

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.

Detailed Description

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See Protocol

Conditions

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Pain Arthritis

Keywords

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Press fit tibial tray

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Xie, PhD

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Stanford University, Department of Orthopedics

Stanford, California, United States

Site Status

Midwest Orthopedics at RUSH University

Chicago, Illinois, United States

Site Status

Physicians Clinic of Iowa

Cedar Rapids, Iowa, United States

Site Status

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Site Status

Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Jordan-Young Institute

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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ORTHO.CR.ROWG2 (US 25)

Identifier Type: -

Identifier Source: org_study_id