NCT04373408

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

3.4 years

First QC Date

April 30, 2020

Last Update Submit

September 17, 2021

Conditions

Anterior Cruciate Ligament RuptureSurgery

Keywords

Anterior Cruciate Ligament RuptureAnterolateral ligamentUltrasonography

Outcome Measures

Primary Outcomes (1)

  • IKDC score

    Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)

    Month 8

Secondary Outcomes (14)

  • IKDC score

    Months 0, 2, 5, 12

  • Lysholm score

    Months 0, 2, 5, 8, 12

  • SANE score

    Months 0, 2, 5, 8, 12

  • Return-to-play

    Months 5, 8, 12

  • Clinical evaluation: reverse pivot shift test

    Months 0, 2, 5, 8, 12

  • +9 more secondary outcomes

Other Outcomes (16)

  • Demographics: Age

    Month 0

  • Demographics: Sex

    Month 0

  • Demographics: timing between the trauma and the surgery

    Month 0

  • +13 more other outcomes

Study Arms (2)

ACL rupture without indication for ALL surgery

Patients with an ACL rupture undergoing surgical repair of the ACL only

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

Procedure: ACL repair with anterolateral repair

Interventions

ACL repair without anterolateral repairPROCEDURE

Surgical repair of the ACL using semitendinous autograft

ACL rupture without indication for ALL surgery
ACL repair with anterolateral repairPROCEDURE

Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)

ACL rupture with indication for ALL surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ACL rupture

You may qualify if:

  • Patients with an ACL rupture and pre-surgical ultrasound evaluation

You may not qualify if:

  • Sedentary patient without sports activities
  • Prior ACL rupture of the same knee
  • Posterior cruciate ligament rupture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Providence

Neuchâtel, 2000, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28727937BACKGROUND

  • 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.

    PMID: 28151693BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Adrien Schwitzguébel, MD

    Hôpital de la Providence

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien Schwitzguébel, MD

CONTACT

0797620562adrien.schwitzguebel@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)