Anterior Cruciate Ligament ReconstructionPhase 1/2NCT00775892
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
A Phase 1/2 study testing SeriACL Device ACL Reconstruction in people with Anterior Cruciate Ligament Reconstruction, run by Serica Technologies, Inc. at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- SeriACL Device ACL Reconstruction
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Major Inclusion Criteria:
- 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
Major Exclusion Criteria:
- Prior ACL reconstruction.
- Severe pain, swelling, or redness
- Complete PCL tear
- Complex menisci tears
- Contralateral knee ligament injury
- OA > Grade II
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Dietrich-Bonhöffer-Klinik
Altentreptow
Medizinische Hochschule Hannover
Hanover
ATOS Clinic
Heidelberg
University of Heidelberg
Heidelberg
About this study
Official title: A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.
- Being tested
- SeriACL Device ACL Reconstruction
- Keywords
- ACL, Ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeriACL Device ACL ReconstructionDevice
Long-term Bioresorbable ACL Scaffold
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events
Measured: 12 months
KT-1000 Arthrometer Knee Laxity
Measured: 12 months
Secondary outcomes (1)
Knee Surveys
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serica Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans Paessler, MD, Principal investigator, ATOS Clinic, HeidelbergJohan Bellemans, MD, Principal investigator, UZ Leuven, BelgiumHolger Schmitt, MD, Principal investigator, Heidelberg UniversityGerhard Oberthaler, MD, Principal investigator, Dr. Pierer Sanatorium, Salzburg, AustriaUwe Pietzner, MD, Principal investigator, Dietrich-Bonhöffer-Klinik, Altentreptow, GermanyMichael Jagodzsinki, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775892
- Sponsor's protocol ID
- CLN-ACL1B
- Status last verified
- Aug 2011
- First submitted
- 16 Oct 2008
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair
- ClinicalTrials.gov ID
- NCT00775892
- Acronym / sponsor ID
- CLN-ACL1B
- Keywords
- ACL, Ligament
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Serica Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeriACL Device ACL ReconstructionLong-term Bioresorbable ACL Scaffold | Device | – |
Primary outcome
Safety - Adverse Events
Time frame: 12 months
KT-1000 Arthrometer Knee Laxity
Time frame: 12 months
1 secondary outcome
Knee Surveys
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Paessler, MD principal investigator
ATOS Clinic, Heidelberg
Johan Bellemans, MD principal investigator
UZ Leuven, Belgium
Holger Schmitt, MD principal investigator
Heidelberg University
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SeriACL Device ACL Reconstruction in people with Anterior Cruciate Ligament Reconstruction, run by Serica Technologies, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Austria, Belgium. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 - Adverse Events (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?
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 9 Aug 2011.