Knee InjuriesNCT04709133
Clinical Outcomes Of Multi-ligament Knee Injuries In Assiut University Hospitals
A study testing multi-ligament knee surgery in people with Knee Injuries, run by Assiut University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- multi-ligament knee surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Amr Abdelnasser contact
About this study
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
Read the 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.
- Conditions
- Knee Injuries
- Being tested
- multi-ligament knee surgery
- Keywords
- Multi-ligament Knee Assiut Outcomes
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-ligament knee surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: multi-ligament knee surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdelnasser Abdelfatah Farghay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709133
- Sponsor's protocol ID
- AssiutUMAAFMD
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29534271
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Of Multi-ligament Knee Injuries In Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04709133
- Acronym / sponsor ID
- AssiutUMAAFMD
- Conditions
- Knee Injuries
- Keywords
- Multi-ligament Knee Assiut Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multi-ligament knee injures | Experimental | Procedure: multi-ligament knee surgeryA 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients presented to emergency department of Assiut University Hospital with knee dislocation.
Key exclusion criteria (6 listed)
- • Advanced knee osteoarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-ligament knee surgerya 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. | Procedure or surgery | multi-ligament knee injures |
Primary outcome
The arabic translated and validated Lysholm Knee Score
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 29534271Fanelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Abdelnasser contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-ligament knee surgery in people with Knee Injuries, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed Abdelnasser, assistant lecturer (01060643674, mohammedabdelnasserdd1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The arabic translated and validated Lysholm Knee Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.