Anterior Cruciate Ligament RuptureALL_USNCT04373408
ALL Ultrasound Predicts the Success of ACL Repair?
An observational study of Anterior Cruciate Ligament Rupture and Surgery, run by Adrien Schwitzguebel at 1 site in Switzerland.
Trial summary
This case series evaluates whether patients with an anterior cruciate ligament (ACL) repair have better outcome if the anterolateral ligament (ALL) was repaired or not considering the ultrasound (US) pre-surgical recommendation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Surgery
- What is being tested?
- ACL repair without anterolateral repair and ACL repair with anterolateral repair
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to Dec 2023
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACL rupture
Who may be able to join
- Patients with an ACL rupture and pre-surgical ultrasound evaluation
Who cannot join
- Sedentary patient without sports activities
- Prior ACL rupture of the same knee
- Posterior cruciate ligament rupture
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Hôpital de la Providence
Neuchâtel, 2000
Adrien Schwitzguébel, MD, 004132 720 32 75, adrien.schwitzguebel@gmail.com
About this study
Official title: Does Anterolateral Ligament Ultrasound Influences the Return-to-play After Anterior Cruciate Ligament Rupture? Survival Analysis
This case series evaluates whether patients with an anterior cruciate ligament (ACL) repair have better outcome if the anterolateral ligament (ALL) was repaired or not considering the ultrasound (US) pre-surgical recommendation.
Read the detailed description
In this case series, the surgeon will decide which patient will have ACL only or ACL and ALL surgery on the basis on multiple parameters. All patient will undergo detailed pre-clinical evaluation, including an ultrasonographic evaluation of the integrity of the ALL.
Two subgroups will be compared for the primary outcome (International Knee Documentation Committee score at 8 months of follow-up). In subgroup 1, the surgeon will follow the ultrasonographic evaluation of the ALL considering the ALL repair (i.e. : ALL intact on the ultrasound, ACL repair only; ALL broken on ultrasound; ACL and ALL repair). In subgroup 2, the surgeon will not follow the ultrasonographic evaluation of the ALL considering the ALL repair.
Secondary outcomes of interest will be evaluated with multivariate regression analysis.
Sample size calculation:
The chosen parameter of interest for the primary outcome evaluation is a continuous response variable (IKDC score) from two independent subgroups (ultrasonographic evaluation of the ALL followed or not for the surgical repair), considering a ratio of 1:3 between the two subgroups. In a previous study (AJSM Sonnery-Cottet 2017) the response within each subject group was normally distributed with standard deviation 13.1. If the true difference between the group means is the published minimal clinically important difference of 9 (AJSM Nwachukwu 2017), we will need to study 30 experimental subjects and 90 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05.
- Conditions
- Anterior Cruciate Ligament Rupture, Surgery
- Being tested
- ACL repair without anterolateral repair, ACL repair with anterolateral repair
- Keywords
- Anterior Cruciate Ligament Rupture, Anterolateral ligament, Ultrasonography
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL repair without anterolateral repairProcedure or surgery
Surgical repair of the ACL using semitendinous autograft
ACL repair with anterolateral repairProcedure or surgery
Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)
| Study group | Role | What they receive |
|---|---|---|
| ACL rupture without indication for ALL surgery | Patients with an ACL rupture undergoing surgical repair of the ACL only Receives: Procedure: ACL repair without anterolateral repair | |
| ACL rupture with indication for ALL surgery | Patients with an ACL rupture undergoing surgical repair of the ACL and the ALL Receives: Procedure: ACL repair with anterolateral repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC score
Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)
Measured: Month 8
Secondary outcomes (14)
IKDC score
Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)
Measured: Months 0, 2, 5, 12
Lysholm score
The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting, scaled between 0 and 100 (100 = good function)
Measured: Months 0, 2, 5, 8, 12
SANE score
The Single Numeric Assessment Evaluation is a subjective percentage of the knee functionality, scaled between 0% and 100% (100% = good function)
Measured: Months 0, 2, 5, 8, 12
Return-to-play
Timing when return-to-play to full sports activities is possible
Measured: Months 5, 8, 12
Clinical evaluation: reverse pivot shift test
Described as "Clunk absent", "Clunk present", or "Clunk present with shake"
Measured: Months 0, 2, 5, 8, 12
Clinical evaluation: anterior drawer test
Described as "Hard stop", "Soft stop", or "Soft stop and increased course"
Measured: Months 0, 2, 5, 8, 12
Clinical evaluation: Lachman test
Described as "Hard stop", "Soft stop", or "Soft stop and increased course"
Measured: Months 0, 2, 5, 8, 12
Clinical evaluation: thigh circumference 10 cm proximal to the patella
measure in cm
Measured: Months 0, 2, 5, 8, 12
Clinical evaluation: thigh circumference 15 cm proximal to the patella
measure in cm
Measured: Months 0, 2, 5, 8, 12
Clinical evaluation: knee extension
Measured in °. Negative values associated with bad outcome
Measured: Months 0, 2, 5, 8, 12
Isokinetic test: knee extensors concentric strength
Measured in absolute value and comparative value with controlateral limb
Measured: Months 5 & 8
Isokinetic test: knee flexors concentric strength
Measured in absolute value and comparative value with controlateral limb
Measured: Months 5 & 8
Isokinetic test: knee flexors eccentric strength
Measured in absolute value and comparative value with controlateral limb
Measured: Months 5 & 8
Rerupture rate
Patients will be evaluated by phone at 3 years of follow-up. Rerupture of the ACL graft (yes-no) will be recorded.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adrien Schwitzguebel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrien Schwitzguebel, Hôpital de la Providence, Switzerland
- Investigators
- Adrien Schwitzguébel, MD, Principal investigator, Hôpital de la Providence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373408
- Sponsor's protocol ID
- ALL Providence
- Acronym
- ALL_US
- Status last verified
- Sep 2021
- First submitted
- 30 Apr 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nwachukwu BU, Chang B, Voleti PB, Berkanish P, Cohn MR, Altchek DW, Allen AA, Williams RJ Rd. Preoperative Short Form Health Survey Score Is Predictive of Return to Play and Minimal Clinically Important Difference at a Minimum 2-Year Follow-up After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 Oct;45(12):2784-2790. doi: 10.1177/0363546517714472. Epub 2017 Jul 20.
PubMed 28727937Sonnery-Cottet B, Saithna A, Cavalier M, Kajetanek C, Temponi EF, Daggett M, Helito CP, Thaunat M. Anterolateral Ligament Reconstruction Is Associated With Significantly Reduced ACL Graft Rupture Rates at a Minimum Follow-up of 2 Years: A Prospective Comparative Study of 502 Patients From the SANTI Study Group. Am J Sports Med. 2017 Jun;45(7):1547-1557. doi: 10.1177/0363546516686057. Epub 2017 Feb 2.
PubMed 28151693
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Anterolateral Ligament Ultrasound Influences the Return-to-play After Anterior Cruciate Ligament Rupture? Survival Analysis
- ClinicalTrials.gov ID
- NCT04373408
- Acronym / sponsor ID
- ALL_US / ALL Providence
- Conditions
- Anterior Cruciate Ligament Rupture, Surgery
- Keywords
- Anterior Cruciate Ligament Rupture, Anterolateral ligament, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Adrien SchwitzguebelUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 May 2020 (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.
This case series evaluates whether patients with an anterior cruciate ligament (ACL) repair have better outcome if the anterolateral ligament (ALL) was repaired or not considering the ultrasound (US) pre-surgical recommendation.
Detailed description
In this case series, the surgeon will decide which patient will have ACL only or ACL and ALL surgery on the basis on multiple parameters. All patient will undergo detailed pre-clinical evaluation, including an ultrasonographic evaluation of the integrity of the ALL.
Two subgroups will be compared for the primary outcome (International Knee Documentation Committee score at 8 months of follow-up). In subgroup 1, the surgeon will follow the ultrasonographic evaluation of the ALL considering the ALL repair (i.e. : ALL intact on the ultrasound, ACL repair only; ALL broken on ultrasound; ACL and ALL repair). In subgroup 2, the surgeon will not follow the ultrasonographic evaluation of the ALL considering the ALL repair.
Secondary outcomes of interest will be evaluated with multivariate regression analysis.
Sample size calculation:
The chosen parameter of interest for the primary outcome evaluation is a continuous response variable (IKDC score) from two independent subgroups (ultrasonographic evaluation of the ALL followed or not for the surgical repair), considering a ratio of 1:3 between the two subgroups. In a previous study (AJSM Sonnery-Cottet 2017) the response within each subject group was normally distributed with standard deviation 13.1. If the true difference between the group means is the published minimal clinically important difference of 9 (AJSM Nwachukwu 2017), we will need to study 30 experimental subjects and 90 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL rupture without indication for ALL surgery | – | Procedure: ACL repair without anterolateral repairPatients with an ACL rupture undergoing surgical repair of the ACL only |
| ACL rupture with indication for ALL surgery | – | Procedure: ACL repair with anterolateral repairPatients with an ACL rupture undergoing surgical repair of the ACL and the ALL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACL rupture
Key inclusion criteria (1 listed)
- Patients with an ACL rupture and pre-surgical ultrasound evaluation
Key exclusion criteria (3 listed)
- Sedentary patient without sports activities
- Prior ACL rupture of the same knee
- Posterior cruciate ligament rupture
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 |
|---|---|---|
| ACL repair without anterolateral repairSurgical repair of the ACL using semitendinous autograft | Procedure or surgery | ACL rupture without indication for ALL surgery |
| ACL repair with anterolateral repairSurgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device) | Procedure or surgery | ACL rupture with indication for ALL surgery |
Primary outcome
IKDC score
Time frame: Month 8
Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)
14 secondary outcomes
IKDC score
Time frame: Months 0, 2, 5, 12
Lysholm score
Time frame: Months 0, 2, 5, 8, 12
SANE score
Time frame: Months 0, 2, 5, 8, 12
Return-to-play
Time frame: Months 5, 8, 12
Clinical evaluation: reverse pivot shift test
Time frame: Months 0, 2, 5, 8, 12
Clinical evaluation: anterior drawer test
Time frame: Months 0, 2, 5, 8, 12
Clinical evaluation: Lachman test
Time frame: Months 0, 2, 5, 8, 12
Clinical evaluation: thigh circumference 10 cm proximal to the patella
Time frame: Months 0, 2, 5, 8, 12
Clinical evaluation: thigh circumference 15 cm proximal to the patella
Time frame: Months 0, 2, 5, 8, 12
Clinical evaluation: knee extension
Time frame: Months 0, 2, 5, 8, 12
Isokinetic test: knee extensors concentric strength
Time frame: Months 5 & 8
Isokinetic test: knee flexors concentric strength
Time frame: Months 5 & 8
Isokinetic test: knee flexors eccentric strength
Time frame: Months 5 & 8
Rerupture rate
Time frame: Year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 28727937Nwachukwu BU, Chang B, Voleti PB, Berkanish P, Cohn MR, Altchek DW, Allen AA, Williams RJ Rd. Preoperative Short Form Health Survey Score Is Predictive of Return to Play and Minimal Clinically Important Difference at a Minimum 2-Year Follow-up After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 Oct;45(12):2784-2790. doi: 10.1177/0363546517714472. Epub 2017 Jul 20.
- Background: PubMed 28151693Sonnery-Cottet B, Saithna A, Cavalier M, Kajetanek C, Temponi EF, Daggett M, Helito CP, Thaunat M. Anterolateral Ligament Reconstruction Is Associated With Significantly Reduced ACL Graft Rupture Rates at a Minimum Follow-up of 2 Years: A Prospective Comparative Study of 502 Patients From the SANTI Study Group. Am J Sports Med. 2017 Jun;45(7):1547-1557. doi: 10.1177/0363546516686057. Epub 2017 Feb 2.
- Individual participant dataSharing planned: No
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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.
Adrien Schwitzguébel, MD principal investigator
Hôpital de la Providence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture and Surgery, run by Adrien Schwitzguebel at 1 site in Switzerland.
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 3 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 23 Sep 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 Switzerland. 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?
Contact Adrien Schwitzguébel, MD (0797620562, adrien.schwitzguebel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC score (time frame: Month 8). 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 NCT04373408, which also lists 2 linked publications.
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 23 Sep 2021.