Acute Ruptures of the Anterior Cruciate LigamentPhase 2/3NCT02183727
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
A Phase 2/3 study testing L-C Ligament and Hamstring Autograft in people with Acute Ruptures of the Anterior Cruciate Ligament, run by Soft Tissue Regeneration, Inc. at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Ruptures of the Anterior Cruciate Ligament
- What is being tested?
- L-C Ligament and Hamstring Autograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Jul 2020
- Phase
- Phase 2/3
- 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
- Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury
Who cannot join
- Prior ACL reconstruction or other surgical procedure on the affected (target) knee
- Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury
- Professional athletes currently engaged in active sport
- Prior distal femoral and/or proximal tibial fracture(s) of the target leg
- Previous or current ACL injury on contra-lateral leg
- Multi-ligament reconstruction
Show all 24Show fewer
- Malalignment or varus thrust
- Patient > 193 cm tall (6' 4")
- The patient does not follow pre-operative rehabilitation that may have been prescribed post-injury (prior to Index Procedure)
- Confirmed connective tissue disorder
- Signs of moderate to severe degenerative joint disease
- Severe pain, swelling, or redness within 24 hours prior to surgery
- Complete or partial Posterior Cruciate Ligament (PCL) tear
- If concomitant meniscal injury is present, any of the following: 1/3rd meniscal resection; complex double-bucket tear; partially repaired meniscal tears
- Any type of lateral and/or medial meniscal tear which is not repairable (<2mm from rim)
- Additional concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion, that are not allowable under the Inclusion criteria
- The patient is unwilling to not participate in sporting activities for at least 9 months post-procedure
- The patient is mentally compromised
- The patient has a neuromuscular disorder that would engender unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care
- The patient has an active or latent infection in or about the affected knee joint or an infection site distant from the knee that may spread to the knee hematogenously
- Pregnant based on a positive beta hCG serum or an in vitro diagnostic test result or breast-feeding
- The patient is obese with a BMI > 35
- The patient has a known allergy to PLLA
- The patient has a medical condition or comorbidity that would interfere with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial
The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.
- Being tested
- L-C Ligament, Hamstring Autograft
- Keywords
- ACL, knee injury, anterior cruciate ligament
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-C LigamentDevice
The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.
Hamstring AutograftProcedure or surgery
The gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated.
| Study group | Role | What they receive |
|---|---|---|
| L-C Ligament | Experimental | Soft Tissue Regeneration's L-C Ligament is an investigation, interventional device intended for ACL reconstruction surgery within 18 weeks of acute rupture of the ACL and no previous surgical treatment. The L-C Ligament temporarily replaces the human anterior cruciate ligament (ACL) and provides a bioresorbable scaffold within and around which the native ACL will regenerate over time. Receives: Device: L-C Ligament |
| Hamstring Autograft | Active comparator | Hamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction. Receives: Procedure: Hamstring Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Failure
Revision surgery rate at one year
Measured: 12 Months
Physical Knee Function measured by the IKDC
Physical Knee Function at 12 Months post procedure
Measured: 12 Months
Secondary outcomes (2)
Pain Score
Pain levels day 1 post-procedure
Measured: Day 1
Adverse event rates
Rate of AEs throughout the first year of follow-up
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 posted8 Jul 2014 (estimated)
- Study startSep 2015
- Primary completionJun 2020
- Study completionJul 2020
Why it stopped: Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ruptures of the Anterior Cruciate LigamentStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soft Tissue Regeneration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kees van Egmond, MD, Principal investigator, Isala Klinieken, Zwolle, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183727
- Sponsor's protocol ID
- LC1060
- Status last verified
- Nov 2021
- First submitted
- 26 Jun 2014
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02183727
- Acronym / sponsor ID
- LC1060
- Keywords
- ACL, knee injury, anterior cruciate ligament
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue study.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soft Tissue Regeneration, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 8 Jul 2014 (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 study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-C Ligament | Experimental | Device: L-C LigamentSoft Tissue Regeneration's L-C Ligament is an investigation, interventional device intended for ACL reconstruction surgery within 18 weeks of acute rupture of the ACL and no previous surgical treatment. The L-C Ligament temporarily replaces the human anterior cruciate ligament (ACL) and provides a bioresorbable scaffold within and around which the native ACL will regenerate over time. |
| Hamstring Autograft | Active comparator | Procedure: Hamstring AutograftHamstring autograft is the active comparator for this study. Autograft tissue is the gold-standard treatment for primary ACL reconstruction. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury
Key exclusion criteria (24 listed)
- Prior ACL reconstruction or other surgical procedure on the affected (target) knee
- Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury
- Professional athletes currently engaged in active sport
- Prior distal femoral and/or proximal tibial fracture(s) of the target leg
- Previous or current ACL injury on contra-lateral leg
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 |
|---|---|---|
| L-C LigamentThe L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL. | Device | L-C Ligament |
| Hamstring AutograftThe gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated. | Procedure or surgery | Hamstring Autograft |
Primary outcome
Graft Failure
Time frame: 12 Months
Revision surgery rate at one year
Physical Knee Function measured by the IKDC
Time frame: 12 Months
Physical Knee Function at 12 Months post procedure
2 secondary outcomes
Pain Score
Time frame: Day 1
Adverse event rates
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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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.
Kees van Egmond, MD principal investigator
Isala Klinieken, Zwolle, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing L-C Ligament and Hamstring Autograft in people with Acute Ruptures of the Anterior Cruciate Ligament, run by Soft Tissue Regeneration, Inc. at 1 site in Netherlands.
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 1 inclusion and 24 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: stopped early, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Data from LC1033 study of same product indicated lower than expected clinical outcomes; company, STR did not have funds to continue 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?
Graft Failure (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 22 Nov 2021.