NCT00490594

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

Enrollment Period

1.3 years

First QC Date

June 20, 2007

Last Update Submit

October 17, 2008

Conditions

Anterior Cruciate LigamentKnee Injuries

Keywords

ACLligamentACL injury

Outcome Measures

Primary Outcomes (2)

  • Safety - measured by device related SAEs

    12 months

  • KT-1000 Arthrometer

    12 months

Secondary Outcomes (2)

  • Knee Surveys

    12 months

  • Return to Work

    12 months

Interventions

ACL Reconstruction (SeriACL™ Device)DEVICE

Bioresorbable ACL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Atos Clinic

Heidelberg, Germany

Location

Heidelberg University

Heidelberg, Germany

Location

Ullevaal Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Knee InjuriesAnterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Lars Engebretsen, MD

    Ullevaal Hospital

    PRINCIPAL INVESTIGATOR

  • Hans Paessler, MD

    ATOS Clinic, Heidelberg

    PRINCIPAL INVESTIGATOR

  • Holger Schmitt, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

June 1, 2007

Primary Completion

October 1, 2008

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

NO(1)DE(2)