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Anterior Cruciate LigamentPhase 1NCT00490594

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

A Phase 1 study testing ACL Reconstruction (SeriACL™ Device) in people with Anterior Cruciate Ligament and Knee Injuries, run by Serica Technologies, Inc. at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Anterior Cruciate Ligament, Knee Injuries
What is being tested?
ACL Reconstruction (SeriACL™ Device)
Type of treatment
Medical device
How many people
30 participants
Where
3 sitesin 2 countries
Study dates
Jun 2007to Oct 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • Atos Clinic

    Heidelberg

  • Heidelberg University

    Heidelberg

Other trials in Germany

Norway1 site

  • Ullevaal Hospital

    Oslo

Other trials in Norway

About this study

Official title: A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair

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.

Being tested
ACL Reconstruction (SeriACL™ Device)
Keywords
ACL, ligament, ACL injury
Medical subject headings
Knee Injuries, Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACL Reconstruction (SeriACL™ Device)Device

    Bioresorbable ACL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - measured by device related SAEs

    Measured: 12 months

  2. KT-1000 Arthrometer

    Measured: 12 months

Secondary outcomes (2)

  1. Knee Surveys

    Measured: 12 months

  2. Return to Work

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490594
Sponsor's protocol ID
CLN-ACL1
Status last verified
Oct 2008
First submitted
20 Jun 2007
Last updated
20 Oct 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACL Reconstruction (SeriACL™ Device) in people with Anterior Cruciate Ligament and Knee Injuries, run by Serica Technologies, Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - measured by device related SAEs (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2008.

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