NCT05817084

Brief Summary

The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

March 10, 2023

Last Update Submit

July 4, 2024

Conditions

ACL - Anterior Cruciate Ligament DeficiencyVarus Deformity of Tibia (Disorder)ACL InjuryKnee Deformity

Outcome Measures

Primary Outcomes (7)

  • Lysholm knee score

    knee score from 0 to 100 where a higher score means better outcome.

    1 month post operative

  • Lysholm knee score

    knee score from 0 to 100 where a higher score means better outcome.

    3 month post operative

  • Lysholm knee score

    knee score from 0 to 100 where a higher score means better outcome.

    6 month post operative

  • Tegner activity level

    activity level from 0 to 11 where 11 means highest level

    1 month post operative

  • Tegner activity level

    activity level from 0 to 11 where 11 means highest level

    3 months post operative

  • Tegner activity level

    activity level from 0 to 11 where 11 means highest level

    6 months post operative

  • Return to pre injury level

    time needed by the patient in months post operative to return to pre injury activity level

    through study completion, an average of 7 months

Secondary Outcomes (2)

  • knee range of motion

    pre operative, 1 month, 3months, and 6 months post operative

  • knee stability

    pre operative, 1 month, 3months, and 6 months post operative

Study Arms (2)

12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto

ACTIVE COMPARATOR

anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session

Procedure: medial opening wedge high tibial osteotomyProcedure: anterior cruciate ligament reconstruction

12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction

ACTIVE COMPARATOR

anterior cruciate ligament reconstruction alone.

Procedure: anterior cruciate ligament reconstruction

Interventions

medial opening wedge high tibial osteotomyPROCEDURE

medial opening wedge valgus high tibial osteotomy

12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto
anterior cruciate ligament reconstructionPROCEDURE

anterior cruciate ligament reconstruction

12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 50.
  • Knee varus malalignment 7-10°.
  • ACL injury with clinical anterior instability confirmed by MRI.

You may not qualify if:

  • Osteoarthritis (Kellgren-Lawrence grade IV).
  • Inflammatory joint disease.
  • Knee flexion \< 120°
  • Knee fixed flexion deformity \> 10°.
  • BMI \>30
  • Any ligamentous or meniscal knee injury other than ACL injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 18, 2023

Study Start

April 1, 2022

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)