NCT00775892

Brief Summary

A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.

Trial Health

85
On Track

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
3 countries

6 active sites

Status
completed

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

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

1.7 years

First QC Date

October 16, 2008

Last Update Submit

August 7, 2011

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACLLigament

Outcome Measures

Primary Outcomes (2)

  • Safety - Adverse Events

    12 months

  • KT-1000 Arthrometer Knee Laxity

    12 months

Secondary Outcomes (1)

  • Knee Surveys

    12 months

Interventions

SeriACL Device ACL ReconstructionDEVICE

Long-term Bioresorbable ACL Scaffold

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Complete rupture of the ACL
  • Passive flexion \>= 120° and passive extension = contralateral knee
  • MCL grade 2 or less
  • Pre-injury Tegner score \>= 4
  • Informed Consent

You may not qualify if:

  • Prior ACL reconstruction.
  • Severe pain, swelling, or redness
  • Complete PCL tear
  • Complex menisci tears
  • Contralateral knee ligament injury
  • OA \> Grade II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dr. Pierer Sanatorium

Salzburg, Austria

Location

UZ Leuven

Leuven, Belgium

Location

Dietrich-Bonhöffer-Klinik

Altentreptow, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

ATOS Clinic

Heidelberg, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

Study Officials

  • Hans Paessler, MD

    ATOS Clinic, Heidelberg

    PRINCIPAL INVESTIGATOR

  • Johan Bellemans, MD

    UZ Leuven, Belgium

    PRINCIPAL INVESTIGATOR

  • Holger Schmitt, MD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

  • Gerhard Oberthaler, MD

    Dr. Pierer Sanatorium, Salzburg, Austria

    PRINCIPAL INVESTIGATOR

  • Uwe Pietzner, MD

    Dietrich-Bonhöffer-Klinik, Altentreptow, Germany

    PRINCIPAL INVESTIGATOR

  • Michael Jagodzsinki, MD

    Hannover Medical School

    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

October 16, 2008

First Posted

October 20, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations

DE(4)BE(1)AU(1)