Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty

NCT ID: NCT03106558

Last Updated: 2017-04-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

Brief Summary

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This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual instrument total knee replacement

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty using Manual Instrumentation

Intervention Type DEVICE

Robitic arm total knee replacement

Group Type ACTIVE_COMPARATOR

Total Knee Arthroplasty using Robotic Arm

Intervention Type DEVICE

Interventions

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Total Knee Arthroplasty using Manual Instrumentation

Intervention Type DEVICE

Total Knee Arthroplasty using Robotic Arm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient requires primary total knee surgery
* Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
* Patient is willing to sign an IRB approved informed consent
* Patient is at least 18 years of age

Exclusion Criteria

* Patient has a BMI \> 50
* Patient is skeletally immature
* Patient has an active infection or suspected infection in or about the joint
* Bone stock that is inadequate to support fixation of the prosthesis
* Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
* Patients with mental or neurological conditions which may be incapable of following instructions.
* Blood supply limitations
* Collateral ligament insufficiency.
* Patients with prior HTOs or Unis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Orthopaedics

INDUSTRY

Sponsor Role collaborator

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Athens Orthopedic Clinic

Athens, Georgia, United States

Site Status

Rothman Institute

Egg Harbor, New Jersey, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2017WHoz

Identifier Type: -

Identifier Source: org_study_id

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