NCT04709133

Brief Summary

Multi-ligament knee injuries (MLKI) are devastating injuries. They are defined as injuries to at least two of the four major ligaments in the knee: anterior cruciate ligament, posterior cruciate ligament, lateral collateral ligament (and posterolateral corner) and medial collateral ligament (and posteromedial corner). These injuries are commonly classified using the Schenck classification system. The incidence of these injuries has been reported to be around 0.02-0.20% of all orthopaedic injuries. However, this is likely to be an underestimation due to spontaneous knee reduction and missed injuries. The immediate management of these injuries is crucial in identifying and treating any vascular and nerve injury. The literature has shown poor outcome and residual instability in those who were treated non-operatively. However, the optimal surgical treatment for these injuries is not known, with differences in opinion amongst treating clinicians. There are controversies in the timing of surgery (early versus delayed), single-staged or two-staged procedures and whether the damaged ligaments should be repaired or reconstructed

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
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration 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

January 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 12, 2021

Last Update Submit

January 13, 2021

Conditions

Knee Injuries

Keywords

Multi-ligament Knee Assiut Outcomes

Outcome Measures

Primary Outcomes (1)

  • The arabic translated and validated Lysholm Knee Score

    a chart review will be performed to identify patients who underwent surgical treatment for multiligamentous knee injuries at Assiut University Hospital performed by one of sports medicine orthopaedic surgeons at Assiut arthroscopy and sport unit.

    6 months

Study Arms (1)

multi-ligament knee injures

EXPERIMENTAL

A chart review will be performed to identify patients who underwent surgical treatment for multiligamentous knee injuries at Assiut University Hospital performed by one of sports medicine orthopaedic surgeons at Assiut arthroscopy and sport unit.

Procedure: multi-ligament knee surgery

Interventions

multi-ligament knee surgeryPROCEDURE

a chart review will be performed to identify patients who underwent surgical treatment for multi-ligamentous knee injuries at Assiut University Hospital performed by one of sports medicine orthopaedic surgeons at Assiut arthroscopy and sport unit.

multi-ligament knee injures

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients presented to emergency department of Assiut University Hospital with knee dislocation.
  • Patients presented to outpatient sport clinics of Assiut University Hospital with two or more ligamentous knee injury.
  • Age from 18-55 years old.
  • Uninjured contralateral knee.
  • Informed consent obtained by the patient.

You may not qualify if:

  • Advanced knee osteoarthritis.
  • Current ipsilateral knee septic arthritis.
  • Patient with current psychological disease.
  • Patient with medically managed severe systemic disease.
  • Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
  • Prisoner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • Fanelli GC, Fanelli DG. Multiple Ligament Knee Injuries. J Knee Surg. 2018 May;31(5):399-409. doi: 10.1055/s-0038-1636910. Epub 2018 Mar 13.

    PMID: 29534271BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

mohammed Abdelnasser, assistant lecturer

CONTACT

01060643674mohammedabdelnasserdd1991@gmail.com

Amr Abdelnasser

CONTACT

01115523789

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at orthopedic and trauma department assiut university hospital

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)