SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL... | NCT00490594

Studies
SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

NCT00490594

Sponsor

Serica Technologies, Inc.

Status

Unknown status

Last Update Posted

Oct 20, 2008Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Anterior Cruciate Ligament
Knee Injuries

Interventions

ACL Reconstruction (SeriACL™ Device)

Countries

Germany
Norway

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

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Oct 2008Estimated

Completion Date

Not provided

First Submitted Date

Jun 20, 2007

First Submission Date that Met QC Criteria

Jun 21, 2007

First Posted Date

Jun 22, 2007Estimated

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

Oct 17, 2008

Last Update Posted Date

Oct 20, 2008Estimated

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 SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair.

This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.

Detailed Description

Not provided

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
ACL Reconstruction (SeriACL™ Device)	Device	Bioresorbable ACL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety - measured by device related SAEs		12 months
KT-1000 Arthrometer		12 months

Secondary Outcomes

Measure	Description	Time Frame
Knee Surveys		12 months
Return to Work		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Complete ACL rupture
Injured knee range of motion >= 75% of contralateral knee
MCL tear grading <= 2
Sign informed consent.

Exclusion criteria:

Prior ACL reconstruction
Complete PCL tear
Locked bucket handle tear or complex tears of the menisci.
Contralateral knee ligament injury
Known joint disease
Known allergy to silk
Active drug or alcohol abuse
Pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Engebretsen, MD	Ullevaal Hospital	Principal Investigator
Hans Paessler, MD	ATOS Clinic, Heidelberg	Principal Investigator
Holger Schmitt, MD	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atos Clinic		Heidelberg			Germany
Heidelberg University

Condition Browse Module

MeSH Terms

ID	Term
D007718	Knee Injuries
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided