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| Name | Class |
|---|---|
| Ramsay Générale de Santé | OTHER |
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The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.
The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.
This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL plasty | Active Comparator | The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure. |
|
| ACL + ALL plasty | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL plasty | Procedure | standard ligamentoplasty by Kenneth Jones |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ligament re-rupture rate | Clinical instability, laximetry, IRM | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee Subjective Knee (IKDC) clinical score | International Knee Documentation Committee Subjective Knee allows a subjective assessment including symptoms, activity and knee function; is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (no limitation with activities of daily living or sports activities and the absence of symptoms) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Jean Mermoz - Centre Paul Santy | Lyon | 69008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41536854 | Derived | Sonnery-Cottet B, Carrozzo A, Poilvache H, Fayard JM, Freychet B, Thaunat M, Vieira TD, Saithna A; Santy Orthopedic Center Group. Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft: a randomised controlled trial with 5-year follow-up. Lancet Reg Health Eur. 2025 Dec 20;62:101561. doi: 10.1016/j.lanepe.2025.101561. eCollection 2026 Mar. | |
| 32490026 |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ACL + ALL plasty |
| Procedure |
standard ligamentoplasty and anterolateral plasty |
|
| preoperatively, 1 year and 3 years |
| Tegner Lysholm score | Specific knee questionnaire : patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). | Preoperatively, 1 year and 3 years |
| Rolimeter test | Antero-posterior laximetry | pre-operatively, 6 months, 1 year and 3 years |
| KiRA test | Rotatory laximetry | preoperatively, 6 months and 3 years |
| Knee radiography | Development of osteoarthritis signs | preoperatively and 3 years |
| Knee injury and osteoarthritis outcome score (KOOS) clinical score | Knee injury and osteoarthritis outcome score is a specific knee questionnaire which evaluates : pain, symptoms, knee function in daily life, knee function in sport practice and quality of life. Scale : None (0) Mild Moderate Severe Extreme (4) Each subscale score is calculated independently. Calculate the mean score of the individual items of each subscale and divide by 4. Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems | preoperative, 1 year and 3 years |
| Derived |
| 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. |