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Clinical Outcomes Of Multi-ligament Knee Injuries In Assiut University Hospitals

Primary Purpose

Knee Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
multi-ligament knee surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Multi-ligament Knee Assiut Outcomes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.

Sites / Locations

  • Faculty of medicine Assiut University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

multi-ligament knee injures

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2021
Last Updated
January 13, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04709133
Brief Title
Clinical Outcomes Of Multi-ligament Knee Injuries In Assiut University Hospitals
Official Title
Clinical Outcomes Of Multi-ligament Knee Injuries In Assiut University Hospitals
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Approximately 50% of all knee dislocations reduce spontaneously before the physician's arrival. Thus, high suspicion must be held, and literally every MLKI must be treated immediately as a true knee dislocation until proven otherwise. Failing to recognize the whole injury pattern around the knee can lead to disastrous consequences. Thus, an initial interdisciplinary systematic approach obtains top priority. Even though diagnostic image instruments become more and more reliable, physical examination still remains a fundamental element in any accurate assessment of knee dislocation. Several authors describe their own experiences and related treatment strategies of knee dislocation. But although a large number of studies about knee dislocation and MLKI do exist in medical databases, the complexity of this injury, the inhomogeneity of literature, and the persevering controversies in their treatment still make it difficult to draw reliable general conclusions. Although important advances have been made in knee arthroscopy, ligament reconstruction and patient management, recommendations are not always applicable in settings with limited resources available. Challenges encountered in these situations include long delays to presentation, as well as the lack of sufficient access to operating room time, arthroscopic equipment, newer fixation devices, and allografts. Patients are often uninsured; work informally as manual laborers and their access to physiotherapy is very limited. The purpose of this study is to analyse our institution's experience with multi-ligament knee injuries via the following items prevalence, detailed initial management at emergency department, types of these injuries, rationale of definitive treatment, rehabilitation protocol, postoperative complications and functional outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Multi-ligament Knee Assiut Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multi-ligament knee injures
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
multi-ligament knee surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
The arabic translated and validated Lysholm Knee Score
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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. Exclusion Criteria: • 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed Abdelnasser, assistant lecturer
Phone
01060643674
Email
mohammedabdelnasserdd1991@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Abdelnasser
Phone
01115523789
Facility Information:
Facility Name
Faculty of medicine Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29534271
Citation
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.
Results Reference
background

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Clinical Outcomes Of Multi-ligament Knee Injuries In Assiut University Hospitals

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