Evaluate the Safety, Functionality, and the Quality of Li... | NCT02056470

Studies
Evaluate the Safety, Functionality, and the Quality of Life of Patients Who Receive the Freedom Total Knee ® System

NCT02056470

Sponsor

Maxx Orthopedics Inc

Status

Completed

Last Update Posted

Mar 30, 2020Actual

Enrollment

211Actual

Phase

Not Applicable

Conditions

Knee Joint Pain

Interventions

Freedom Total Knee
Total Knee Replacement
Freedom Total Knee System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Mar 2020Actual

First Submitted Date

Feb 3, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2020

Last Update Posted Date

Mar 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery versus Post-Surgery data for:

Range of Motion
Quality of Life measurements using Knee Society Scale (KSS)
Survivorship as defined by 'No Revision' of baseline implant
Quality of Life measurements using the WOMAC Score

Detailed Description

The clinical study will involve a series of evaluations performed by your surgeon. These examinations are consistent with the normal surgeon care as part of Total Knee Replacement surgery. The study objective is to assess the safety, functionality, and survivorship of the Freedom Knee System through a multi-center clinical trial. Study endpoints include a comparison of Pre-Surgery (baseline) versus Post-Surgery data for Range of Motion and Flexion, Quality of Life (KSS), and survivorship (defined by 'no revisions'). Additionally, the structural integrity will be evaluated based on the x-ray performed 36-months after knee replacement.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

211Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Freedom Total Knee Replacement	Experimental	Freedom Total Knee	Device: Freedom Total Knee Device: Total Knee Replacement Device: Freedom Total Knee System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Freedom Total Knee	Device	The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement	Freedom Total Knee Replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the safety and functionality of the Freedom Knee® system through a multi-center clinical trial	The study is hoping to assess the safety of the implant by looking at the incident of revisions to the implant post surgery up to and including 3 years	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and Females 40-80 years of age
Patients requiring knee prosthesis, and have been evaluated as appropriate candidates for aTKA by their orthopedic surgeon
Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation

Exclusion Criteria:

Previous major knee replacement of the affected knee joint
Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, nueropathic joints)
Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI > 35)
Patients who are found to be non-compliant by their physician
Patients with or having; malignancy - active malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
The patient has a neuromuscular or neurosensory deficit.
Female patients planning a pregnancy during the course of the study.
Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
Varus or valgus deformity > 20 degrees

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert W Eberle	Director, Clinical Affairs	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Maxx Ortho		Norristown	Pennsylvania	19403	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

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Browse Branches

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