Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2020-07-01
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ACL rupture without indication for ALL surgery
Patients with an ACL rupture undergoing surgical repair of the ACL only
ACL repair without anterolateral repair
Surgical repair of the ACL using semitendinous autograft
ACL rupture with indication for ALL surgery
Patients with an ACL rupture undergoing surgical repair of the ACL and the ALL
ACL repair with anterolateral repair
Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)
Interventions
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ACL repair without anterolateral repair
Surgical repair of the ACL using semitendinous autograft
ACL repair with anterolateral repair
Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior ACL rupture of the same knee
* Posterior cruciate ligament rupture
18 Years
65 Years
ALL
No
Sponsors
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Adrien Schwitzguebel
OTHER
Responsible Party
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Adrien Schwitzguebel
MD
Principal Investigators
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Adrien Schwitzguébel, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Providence
Locations
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Hôpital de la Providence
Neuchâtel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Sonnery-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.
Other Identifiers
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ALL Providence
Identifier Type: -
Identifier Source: org_study_id
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