NCT05461625

Brief Summary

This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.

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
762

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

February 3, 2022

Last Update Submit

July 13, 2022

Conditions

ACL InjuryALL

Keywords

ACL, ALL

Outcome Measures

Primary Outcomes (1)

  • Knee stability

    KT-1000 assesment for knee stability

    24 months

Secondary Outcomes (19)

  • Functional tests

    12 months

  • KOOS (Knee injury and Osteoarthritis Outcome Score)

    6 weeks

  • KOOS (Knee injury and Osteoarthritis Outcome Score)

    6 months

  • KOOS (Knee injury and Osteoarthritis Outcome Score)

    24 months

  • Tegner Lysholm Knee Scoring Scale

    6 weeks

  • +14 more secondary outcomes

Study Arms (3)

ACL

SHAM COMPARATOR

Anterior cruciate ligament reconstruction without additional procedure

Procedure: ACL reconstruction

ACL + ALL anatomic

ACTIVE COMPARATOR

Anterior cruciate ligament reconstruction and anatomic anterolateral ligament reconstruction

Procedure: ACL reconstructionOther: ALL anatomic

ACL + ALL tenodesis

ACTIVE COMPARATOR

Anterior cruciate ligament reconstruction and anterolateral ligament tenodesis

Procedure: ACL reconstructionOther: ALL tenodesis

Interventions

ACL reconstructionPROCEDURE

Anterior cruciate ligament reconstruction

ACLACL + ALL anatomicACL + ALL tenodesis
ALL anatomicOTHER

anatomic anterolateral ligament reconstruction

ACL + ALL anatomic
ALL tenodesisOTHER

anterolateral ligament teondesis

ACL + ALL tenodesis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- primary ACL injury

You may not qualify if:

  • no informed consent to participate in the study
  • age under 18 years or above 65
  • multilligament injury or single plane knee instability (medial, lateral)
  • another musculoskeletal disorders in lower limb
  • lower limb deformity requiring axis correction below 4o or above 12.5o
  • joints inflammatory diseases
  • ASA score \> II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital

Otwock, Masovian Voivodeship, 05-400, Poland

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Rafal Kaminski

    SPSK CMKP

    STUDY CHAIR

Central Study Contacts

Rafal Kaminski

CONTACT

+48227794031rkamiski@spskgruca.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor CMKP

Study Record Dates

First Submitted

February 3, 2022

First Posted

July 18, 2022

Study Start

September 1, 2021

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

PL(1)