NCT03850262

Brief Summary

The posterolateral corner (PLC) is known as the "dark side of the knee" due to its complex and variable anatomy.Its stability is provided by capsular and non-capsular structures that function as static and dynamic stabilizers. The structures of the PLC are primarily responsible for resisting varus angulation and external tibial rotation. They also act as secondary stabilizers, in conjunction with the cruciate ligaments, to prevent anterior and posterior translation during the early phase of flexion (0°-30°) PLC injures are relatively uncommon, occurring in approximately 16% of all knee injuries. They are rarely seen in isolation, as the majority is associated with concomitant cruciate ligament tears, as well as meniscal tears and injuries to the medial ligamentous structure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

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

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
2.6 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

February 19, 2019

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of MRI in diagnosis of forty patients with posterolateral corner trauma of the knee.

    MRI at Radiological department will be done to evaluate injuries of PLC posterolateral corner of the knee in correlation with clinical or operative findings (either open or arthroscopic) as gold standard.

    one year

Study Arms (1)

patients with posterolateral corner trauma of the knee

Radiation: MRI

Interventions

MRIRADIATION

The study will be done on 1.5T MR unit (Siemens) and 1.5T MR unit (Philips) at Assuit University Hospital, or 1.5T MR unit (G.E.) at Eman General Hospital. * The field of view varied between 14 cm and 16 cm, and slice thickness varied between 3 and 4 mm, with 0.5 mm intersection gap. * Imaging sequences included sagittal PD proton density, T2 and STIR, axial PD, coronal STIR and coronal oblique.

patients with posterolateral corner trauma of the knee

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with posterolateral corner trauma of the knee

You may qualify if:

  • Patients have positive tests of posterolateral corner instability by clinical examination.
  • Patients who suspected by Plain X-ray to have posterolateral corner injury.

You may not qualify if:

  • Patients whom previously underwent arthroscopy or surgically intervention to knee joint.
  • Patients with history of fracture repaired by metal plates or screws.
  • Patients have phobia of indoor places.
  • Patients with contraindication to MRI like intra-cerebral aneurysmal clips, cardiac pacemaker, and metallic foreign body at region of examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fornalski S, McGarry MH, Csintalan RP, Fithian DC, Lee TQ. Biomechanical and anatomical assessment after knee hyperextension injury. Am J Sports Med. 2008 Jan;36(1):80-4. doi: 10.1177/0363546507308189. Epub 2007 Oct 11.

    PMID: 17932409BACKGROUND
  • Baker CL Jr, Norwood LA, Hughston JC. Acute posterolateral rotatory instability of the knee. J Bone Joint Surg Am. 1983 Jun;65(5):614-8.

    PMID: 6853566BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

January 14, 2021

Record last verified: 2021-01