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

Primary Purpose

Anterior Cruciate Ligament, Knee Injuries

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ACL Reconstruction (SeriACL™ Device)
Sponsored by
Serica Technologies, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament focused on measuring ACL, ligament, ACL injury

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atos Clinic
  • Heidelberg University
  • Ullevaal Hospital

Outcomes

Primary Outcome Measures

Safety - measured by device related SAEs
KT-1000 Arthrometer

Secondary Outcome Measures

Knee Surveys
Return to Work

Full Information

First Posted
June 20, 2007
Last Updated
October 17, 2008
Sponsor
Serica Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00490594
Brief Title
SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction
Official Title
A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Serica Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament, Knee Injuries
Keywords
ACL, ligament, ACL injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ACL Reconstruction (SeriACL™ Device)
Intervention Description
Bioresorbable ACL
Primary Outcome Measure Information:
Title
Safety - measured by device related SAEs
Time Frame
12 months
Title
KT-1000 Arthrometer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Knee Surveys
Time Frame
12 months
Title
Return to Work
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Engebretsen, MD
Organizational Affiliation
Ullevaal Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Paessler, MD
Organizational Affiliation
ATOS Clinic, Heidelberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holger Schmitt, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atos Clinic
City
Heidelberg
Country
Germany
Facility Name
Heidelberg University
City
Heidelberg
Country
Germany
Facility Name
Ullevaal Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

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

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