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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COMPLETED
NA
592 participants
INTERVENTIONAL
2016-11-02
2024-06-10
Brief Summary
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Detailed Description
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This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :
* operated by a conventional patellar tendon technique (first group)
* operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ACL plasty
The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure.
ACL plasty
standard ligamentoplasty by Kenneth Jones
ACL + ALL plasty
The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure.
ACL + ALL plasty
standard ligamentoplasty and anterolateral plasty
Interventions
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ACL plasty
standard ligamentoplasty by Kenneth Jones
ACL + ALL plasty
standard ligamentoplasty and anterolateral plasty
Eligibility Criteria
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Inclusion Criteria
* Patients between 18 and 35 years old
* Patients with weekly sporting activities
* Patients with chronic rotatory instability with a positive pivot shift
* Patients who have been informed and do not object the research
Exclusion Criteria
* Patients under 18 years old or over 35 years old
* Patients with a BMI of under 18.5 or over 30
* Patients with any contraindication to general anaesthesia
* Professional sportsmen/women
* Patients with congenital malformation or a rheumatic disease
* Patients with repeated antero crusader ligament (ACL) rupture
* Patients with serious ligament disease in the contralateral knee
* Patients who refuse to take part in the study
18 Years
35 Years
ALL
No
Sponsors
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Ramsay Générale de Santé
OTHER
Ascopharm Groupe Novasco
OTHER
Responsible Party
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Locations
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Hôpital Privé Jean Mermoz - Centre Paul Santy
Lyon, , France
Countries
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References
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Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.
Other Identifiers
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2016-A00144-47
Identifier Type: -
Identifier Source: org_study_id
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