Ruptured Achilles TendonNCT04114708
MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis
A study testing Anterior cruciate ligament Reconstruction (ACLR) and ACLR with lateral extra-articular tenodesis (LET) in people with Ruptured Achilles Tendon, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Ruptured Achilles Tendon
- What is being tested?
- Anterior cruciate ligament Reconstruction (ACLR) and ACLR with lateral extra-articular tenodesis (LET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Oct 2022
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ACL deficient knee
- skeletally mature (as defined by closed growth plates on plain radiograph)
- at least 13 years of age
- less than 26 years of age
- not pregnant
- two or more of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
- no concomitant lateral meniscus tear
Who cannot join
- knee with intact ACL
- skeletally immature (as defined by open physis on plain radiograph)
- less than two of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
- pregnant
- less than 13 years of age
- older than age 25
Show all 11Show fewer
- previous ACL repair
- concomitant lateral meniscus tear
- unable to speak english or perform informed consent
- multiligamentous knee injury (two or more ligaments requiring surgical attention)
- varus or valgus malalignment greater than 3 degrees
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.
- Conditions
- Ruptured Achilles Tendon
- Being tested
- Anterior cruciate ligament Reconstruction (ACLR), ACLR with lateral extra-articular tenodesis (LET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cruciate ligament Reconstruction (ACLR)Diagnostic test
All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft.
ACLR with lateral extra-articular tenodesis (LET)Diagnostic test
All LETs will be performed in a standardized fashion using the modified Lameire technique. All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft.
| Study group | Role | What they receive |
|---|---|---|
| ACLR | Other | All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft. Receives: Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR) |
| ACLR with lateral extra-articular tenodesis | Other | All LETs will be performed in a standardized fashion using the modified Lameire technique. Receives: Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone
MRI findings will be compared in patients receiving ACLR+LET versus just ACLR
Measured: 1 Year
Secondary outcomes (1)
Graft Failure
Defined as either symptomatic instability requiring revision or symptomatic instability with positive pivot shift or asymmetrical pivot shift greater than the contralateral side.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study startJan 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Achilles TendonStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Alaia, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114708
- Sponsor's protocol ID
- 19-01185
- Status last verified
- Jul 2022
- First submitted
- 24 Sep 2019
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Review of ACLR With and Without Lateral Extra-articular Tenodesis
- ClinicalTrials.gov ID
- NCT04114708
- Acronym / sponsor ID
- 19-01185
- Conditions
- Ruptured Achilles Tendon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 3 Oct 2019 (actual)
- 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 the proposed study is to evaluate the effect of lateral extra-articular tenodesis (LET) on anterior cruciate ligament reconstruction through evaluation of postoperative magnetic resonance imaging (MRI). This will be a single-center non-randomized controlled study. The study is comparing postoperative graft MRI findings in two cohorts: patients undergoing isolated ACLR and patients undergoing ACLR with lateral extra-articular tenodesis (LET). Postoperative MRIs will be obtained at 6, 9 and 12 months postoperatively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACLR | Other | Diagnostic Test: Anterior cruciate ligament Reconstruction (ACLR)All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft. |
| ACLR with lateral extra-articular tenodesis | Other | Diagnostic Test: ACLR with lateral extra-articular tenodesis (LET)All LETs will be performed in a standardized fashion using the modified Lameire technique. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ACL deficient knee
- skeletally mature (as defined by closed growth plates on plain radiograph)
- at least 13 years of age
- less than 26 years of age
- not pregnant
Key exclusion criteria (11 listed)
- knee with intact ACL
- skeletally immature (as defined by open physis on plain radiograph)
- less than two of following criteria: competitive pivoting sport, grade 2 pivot shift or - greater, generalized ligament laxity (beighton score of 4 or greater )
- pregnant
- less than 13 years of age
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 |
|---|---|---|
| Anterior cruciate ligament Reconstruction (ACLR)All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft. | Diagnostic test | ACLR |
| ACLR with lateral extra-articular tenodesis (LET)All LETs will be performed in a standardized fashion using the modified Lameire technique. All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft. | Diagnostic test | ACLR with lateral extra-articular tenodesis |
Primary outcome
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone
Time frame: 1 Year
MRI findings will be compared in patients receiving ACLR+LET versus just ACLR
1 secondary outcome
Graft Failure
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Michael Alaia, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cruciate ligament Reconstruction (ACLR) and ACLR with lateral extra-articular tenodesis (LET) in people with Ruptured Achilles Tendon, run by NYU Langone Health at 1 site in United States.
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 8 Jul 2022. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determine if ACLR supplementation with LET results in superior MRI findings relative to ACLR alone (time frame: 1 Year). 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 8 Jul 2022.