NCT05391672

Brief Summary

Clinical evaluation for the patients with partial ACL tear who had ACL augmentation

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

May 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

June 9, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2026

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

May 21, 2022

Last Update Submit

December 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The main outcome is difference in IKDC scores between the patients

    we will evaluate the clinical outcome post operative mainly according to the difference in IKDC score between the patients

    Baseline

Study Arms (1)

Augmentation group

OTHER

We will use hamstring graft in which fixation of graft will be by adjustable loop devices for femoral part fixation \& Bioscrews +/- staples for tibial part fixation

Procedure: we will do ACL augmentation surgery to the patients who have partial ACL tear

Interventions

we will do ACL augmentation surgery to the patients who have ACL partial tear using hamstring graft and fixation of the graft to the femoral part by adjustable loop and tibial part with Bio or peak screws +\\- staples.

Augmentation group

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age from 15 to 50 years old
  • Partial ACL tear without any other ligament injury
  • with and without meniscal tear
  • with and without knee deformity
  • recent and chronic injury

You may not qualify if:

  • younger than 15 and older than 50 y
  • multiligament injury
  • complete ACL tear
  • failed ACL reconstruction or repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiyt University

Asyut, Egypt

RECRUITING

Related Publications (4)

  • Gobbi A, Whyte GP. Long-term Outcomes of Primary Repair of the Anterior Cruciate Ligament Combined With Biologic Healing Augmentation to Treat Incomplete Tears. Am J Sports Med. 2018 Dec;46(14):3368-3377. doi: 10.1177/0363546518805740. Epub 2018 Nov 6.

    PMID: 30398894BACKGROUND
  • Dallo I, Chahla J, Mitchell JJ, Pascual-Garrido C, Feagin JA, LaPrade RF. Biologic Approaches for the Treatment of Partial Tears of the Anterior Cruciate Ligament: A Current Concepts Review. Orthop J Sports Med. 2017 Jan 25;5(1):2325967116681724. doi: 10.1177/2325967116681724. eCollection 2017 Jan.

    PMID: 28210653BACKGROUND
  • Sabat D, Kumar V. Partial tears of anterior cruciate ligament: Results of single bundle augmentation. Indian J Orthop. 2015 Mar-Apr;49(2):129-35. doi: 10.4103/0019-5413.152394.

    PMID: 26015599BACKGROUND
  • Sharp JW, Kani KK, Gee A, Mulcahy H, Chew FS, Porrino J. Anterior cruciate ligament fixation devices: Expected imaging appearance and common complications. Eur J Radiol. 2018 Feb;99:17-27. doi: 10.1016/j.ejrad.2017.12.006. Epub 2017 Dec 9.

    PMID: 29362147BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Mohamed Abd-El Radi, Lecturer

    Orthopaedic Department , Faculty of medicine, Assiut University

    STUDY DIRECTOR

Central Study Contacts

Michael Mikhaeil, Resident

CONTACT

Mohamed Abd-El Radi, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective case series study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael Mikhaeil

Study Record Dates

First Submitted

May 21, 2022

First Posted

May 26, 2022

Study Start

June 9, 2022

Primary Completion

March 19, 2026

Study Completion

March 19, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations