Evaluation of the VEGA Knee System® Range of Motion | NCT01768871

Studies
Evaluation of the VEGA Knee System® Range of Motion

NCT01768871

Sponsor

Aesculap Implant Systems

Status

Terminated

Last Update Posted

Nov 14, 2018Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Patients With Total Knee Arthroplasty Using the VEGA System

Interventions

Not provided

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

Nov 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jan 14, 2013

First Submission Date that Met QC Criteria

Jan 15, 2013

First Posted Date

Jan 16, 2013Estimated

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

Nov 12, 2018

Last Update Posted Date

Nov 14, 2018Actual

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

The primary objective of this study is to evaluate the function of the knee after a total knee replacement with the VEGA system®.

Detailed Description

To evaluate patients after total knee arthroplasty in terms of function for five years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOMAC	WOMAC function score 2 years post arthroplasty	Two years

Secondary Outcomes

Measure	Description	Time Frame
Health related quality of life		Two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

willing to sign the informed consent.
Patient has intact collateral ligaments.

Exclusion Criteria:

Inflammatory arthritis
Patients that have had a high tibial osteotomy or femoral osteotomy
Patients with neuromuscular or neurosensory deficiency which would make it difficult to assess the device performance.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have undergone a total knee arthroplasty with the VEGA knee system®

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Khaled Saleh	Southern Illinois University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rose Medical Center		Denver	Colorado	80220	United States
DBA Hussamy Sports and Hand Center