Outcome EnduRo Versus LINK SL Rotating Hinge Knee | NCT01952938

Studies
Outcome EnduRo Versus LINK SL Rotating Hinge Knee

NCT01952938

Sponsor

Orthopaedische Klinik Koenig-Ludwig-Haus

Status

Unknown status

Last Update Posted

Sep 30, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Knee Arthrosis,

Interventions

LINK SL versus EnduRo

Countries

Germany

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

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Not provided

First Submitted Date

Sep 25, 2013

First Submission Date that Met QC Criteria

Sep 27, 2013

First Posted Date

Sep 30, 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

Sep 27, 2013

Last Update Posted Date

Sep 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. Hypothesis: No difference in the clinical outcome for 1 year after the operation. Clinical follow-ups at 3, 10, 90 and 360 days after surgery. Measurement of clinical parameters

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LINK SL		Patients	Procedure: LINK SL versus EnduRo
EnduRo		Patients	Procedure: LINK SL versus EnduRo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LINK SL versus EnduRo	Procedure		EnduRo LINK SL

Measure	Description	Time Frame
Oxford knee score		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rotating hinge knee indicated

Exclusion Criteria:

infection,
malignant tumor,
rheumatism

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients need hinged knee prosthesis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopeadische Klinik KLH	Recruiting	Würzburg	Bavaria	97074	Germany