Ruptured Anterior Cruciate LigamentsZ-LigNCT01245400
Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
A study testing Z-Lig and allograft in people with Ruptured Anterior Cruciate Ligaments, run by Aperion Biologics, Inc. at 6 sites in 6 countries.
Trial summary
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ruptured Anterior Cruciate Ligaments
- What is being tested?
- Z-Lig and allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Nov 2010to Apr 2017
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Contact Sponsor
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
Read the detailed description
Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality).
There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.
- Conditions
- Ruptured Anterior Cruciate Ligaments
- Being tested
- Z-Lig, allograft
- Keywords
- Z-Lig, allograft, ACL, Anterior Cruciate Ligament, ACLR, Anterior Cruciate Ligament Reconstruction, EU, European Union, S. Africa, Reconstruction of ruptured anterior cruciate ligaments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-LigDevice
ACL replacement
allograftDevice
ACL replacement
| Study group | Role | What they receive |
|---|---|---|
| Z-Lig | Experimental | Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure. Receives: Device: Z-Lig |
| Allograft | Active comparator | Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure. Receives: Device: allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
KT-1000
Contact Sponsor
Measured: baseline, 3,6, 12 & 24 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2014 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Anterior Cruciate LigamentsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aperion Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245400
- Sponsor's protocol ID
- ABI-ZLig-01-10-01
- Acronym
- Z-Lig
- Status last verified
- Mar 2014
- First submitted
- 1 Nov 2010
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments
- ClinicalTrials.gov ID
- NCT01245400
- Acronym / sponsor ID
- Z-Lig / ABI-ZLig-01-10-01
- Conditions
- Ruptured Anterior Cruciate Ligaments
- Keywords
- Z-Lig, allograft, ACL, Anterior Cruciate Ligament, ACLR, Anterior Cruciate Ligament Reconstruction, EU, European Union
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aperion Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 22 Nov 2010 (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.
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.
Detailed description
Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality).
There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-Lig | Experimental | Device: Z-LigZ-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure. |
| Allograft | Active comparator | Device: allograftAllograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure. |
Who may qualify
- Ages
- 18 to 60 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 |
|---|---|---|
| Z-LigACL replacement | Device | Z-Lig |
| allograftACL replacement | Device | Allograft |
Primary outcome
KT-1000
Time frame: baseline, 3,6, 12 & 24 monhts
Contact Sponsor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Click here for more information about this study: Z-Lig compared to AllograftLink provided by the sponsor.
Related trials for Ruptured Anterior Cruciate Ligaments
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Benefits of Ballistic Tests After the Anterior Cruciate Ligament Surgery
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-Lig and allograft in people with Ruptured Anterior Cruciate Ligaments, run by Aperion Biologics, Inc. at 6 sites in 6 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: status not confirmed, as of the sponsor's last update on 13 Mar 2014. 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 Belgium, Denmark, Italy, Netherlands, South Africa and 1 more country. 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.
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?
KT-1000 (time frame: baseline, 3,6, 12 & 24 monhts). 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 13 Mar 2014.