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Clinical Trials/NCT05962580
NCT05962580
Completed
Not Applicable

of Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-Articular Tenodesis Between High Demand Patients: Randomized Controlled Trial

Ain Shams University1 site in 1 country20 target enrollmentFebruary 15, 2021
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ConditionsAnterior Cruciate Ligament Tear

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Tear
Sponsor
Ain Shams University
Enrollment
20
Locations
1
Primary Endpoint
failure rate
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Anterior Cruciate Ligament Reconstruction with and without Lateral Extra-Articular Tenodesis between high demand patients

Detailed Description

It is a randomized control trial comparing between isolated anterior cruciate ligament reconstruction with and without lateral extra articular tenodesis between high demand and high risk groups with high pivot regarding failure rate (primary out come) and patient reported functions score (IKDC and Lysholm)

Registry
clinicaltrials.gov
Start Date
February 15, 2021
End Date
March 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •High demand patients (manual workers, athletes,...etc.).
  • •Normal average body mass index ( 18.5 - 24.9 ).
  • •Age \<40 years old.
  • •Patients will be diagnosed as ACL tear by the following:
  • •History of knee traumatic event.
  • •Clinical examination ( positive Lachman test and pivot shift test).
  • •Radiological evidence of ACL tear by MRI.
  • •patient with high pivot shift test.

Exclusion Criteria

  • •Generalized ligamentous laxity.
  • •Other intra or extra articular knee injuries.
  • •Previous ACL surgery on the affected knee.
  • •Bilateral ACL injuries.
  • •Significant Articular surface injury.
  • •Medical comorbidities
  • •Patients with malalignment ( genu varum, genu valgum or genu recurvatum )
  • •Neuromuscular disorders
  • •Knee arthritic changes.

Outcomes

Primary Outcomes

failure rate

Time Frame: one year follow up

retear of ACL graft confirmed by clinical examination and MRI

Secondary Outcomes

  • antero-posterior instability measure(at 3,6,9 and 12 months)
  • International knee documentation committee score (IKDC)(at 3,6,9,12 months)
  • Lysholm score(at 3,6,9,12 months)
  • side to side KT 1000 lachmeter difference(one year follow up)

Study Sites (1)

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