Optetrak Posterior Stabilized Versus Optetrak Hi-Flex | NCT00808613

Studies
Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

NCT00808613

Sponsor

Exactech

Status

Withdrawn

Last Update Posted

Sep 1, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Arthropathy of Knee
Arthritis and/or Post-traumatic Degenerative Problems

Interventions

Optetrak PS
Optetrak Hi-Flex

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn prior to initiation

Expanded Access Info

Start Date

Dec 2008Estimated

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Dec 15, 2008

First Submission Date that Met QC Criteria

Dec 15, 2008

First Posted Date

Dec 16, 2008Estimated

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

Aug 29, 2022

Last Update Posted Date

Sep 1, 2022Actual

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

Detailed Description

The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized ("Optetrak® PS", Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ ("Optetrak® HF", Exactech, Gainesville, FL) knee designs. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optetrak Posterior Stabilized TKR	Active Comparator	Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system.	Device: Optetrak PS
Optetrak Hi-Flex TKR	Active Comparator	Subjects in this arm will receive an Optetrak Hi-Flex total knee system.	Device: Optetrak Hi-Flex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optetrak PS	Device	Optetrak Posterior Stabilized total knee replacement	Optetrak Posterior Stabilized TKR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion.	Physician assess range of motion in knee joint	2 years

Secondary Outcomes

Measure	Description	Time Frame
Knee Society Score (KSS)	Validated physician assessed outcome	2 years
Hospital for Special Surgery (HSS) Knee Score	Validated physician assessed outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is indicated for total knee replacement with a posterior stabilized device.
Patient is between the ages of 50 and 80 years old
Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method)

• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
Patient is skeletally mature.
Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires.
Patient is willing and able to review and sign a study Informed Consent.

Exclusion Criteria:

Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method)

• BMI = Weight (lbs.) ÷ Height (in.)2 x 703
Patient is skeletally mature
Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires.
Patient is willing and able to review and sign a study Informed Consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jason Drenning, Ph.D.	Exactech	Study Director
John W. Aldridge, MD	Hampton Roads Orthopedics	Principal Investigator