NCT03740022

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
592

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 years until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

7.6 years

First QC Date

November 29, 2016

Last Update Submit

November 21, 2024

Conditions

Anterior Cruciate Ligament InjuryLigament Rupture

Outcome Measures

Primary Outcomes (1)

  • Ligament re-rupture rate

    Clinical instability, laximetry, IRM

    3 years

Secondary Outcomes (6)

  • International Knee Documentation Committee Subjective Knee (IKDC) clinical score

    preoperatively, 1 year and 3 years

  • Tegner Lysholm score

    Preoperatively, 1 year and 3 years

  • Rolimeter test

    pre-operatively, 6 months, 1 year and 3 years

  • KiRA test

    preoperatively, 6 months and 3 years

  • Knee radiography

    preoperatively and 3 years

  • +1 more secondary outcomes

Study Arms (2)

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.

Procedure: ACL plasty

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.

Procedure: ACL + ALL plasty

Interventions

ACL plastyPROCEDURE

standard ligamentoplasty by Kenneth Jones

ACL plasty
ACL + ALL plastyPROCEDURE

standard ligamentoplasty and anterolateral plasty

ACL + ALL plasty

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
  • 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

You may not qualify if:

  • Patients with multi-ligament knee involvement
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jean Mermoz - Centre Paul Santy

Lyon, 69008, France

Location

Related Publications (2)

  • 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.

    PMID: 41536854DERIVED

  • 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.

    PMID: 32490026DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

November 14, 2018

Study Start

November 2, 2016

Primary Completion

June 10, 2024

Study Completion

June 10, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

FR(1)