NCT05962580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 6, 2023

Last Update Submit

July 25, 2023

Conditions

Anterior Cruciate Ligament Tear

Keywords

anterior cruciate ligament tearanterolateral instabilityretearextra articular tenodesis

Outcome Measures

Primary Outcomes (1)

  • failure rate

    retear of ACL graft confirmed by clinical examination and MRI

    one year follow up

Secondary Outcomes (4)

  • International knee documentation committee score (IKDC)

    at 3,6,9,12 months

  • Lysholm score

    at 3,6,9,12 months

  • antero-posterior instability measure

    at 3,6,9 and 12 months

  • side to side KT 1000 lachmeter difference

    one year follow up

Study Arms (2)

Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis

EXPERIMENTAL

Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction with modified Lemiere technique for extra-articular tenodesis

Procedure: Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesis

Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis

ACTIVE COMPARATOR

Arthroscopic anatomical single bundle anterior cruciate ligament reconstruction only

Procedure: Isolated anterior cruciate ligament reconstruction only

Interventions

Isolated anterior cruciate ligament reconstruction with lateral extra articular tenodesisPROCEDURE

Anatomical single bundle ACLR with modified Lemiere technique

Isolated anterior cruciate ligament recnostruction with lateral extra articular tenodesis
Isolated anterior cruciate ligament reconstruction onlyPROCEDURE

arthroscopic anatomical single bundle ACL Reconstruction

Isolated anterior cruciate ligament recnostruction without lateral extra articular tenodesis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdel Salam Abdel Halim

Cairo, Abbasia, 11539, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Amr Mo Abdelhady, Professor

    Faculty of medecine, Ain shams university

    STUDY CHAIR

  • Mohamed Ha Sobhey, Professor

    Faculty of medecine, Ain shams university

    STUDY DIRECTOR

  • Moustapha Al ElAbd, lecturer

    Faculty of medecine, Ain shams university

    STUDY DIRECTOR

  • Yehia Mo Haroun, Lecturer

    Faculty of medecine, Ain shams university

    STUDY DIRECTOR

  • Ahmed Ab Amer, Msc

    Faculty of medecine, Ain shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 27, 2023

Study Start

February 15, 2021

Primary Completion

February 15, 2022

Study Completion

March 1, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

EG(1)