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Repair Versus Augmentation of Partial ACL Tear

Primary Purpose

ACL Injury

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Repair or Aumentation of partial ACL tear

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Repair group

Augmentation group

Arm Description

Repair of partial torn ACL by suturing stump and fixation to femoral footprint by anchors

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

Outcomes

Primary Outcome Measures

The main outcome is difference in IKDC scores between two groups of patients

Secondary Outcome Measures

Full Information

NCT ID

NCT05391672

First Posted

May 21, 2022

Last Updated

July 22, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05391672

Brief Title

Repair Versus Augmentation of Partial ACL Tear

Official Title

Repair Versus Augmentation Of Partial Anterior Cruciate Ligament Tear

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2022 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Comparison between ACL repair and ACL augmentation in symptomatic patients with partial ACL injury

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ACL Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Repair group

Arm Type

Other

Arm Description

Repair of partial torn ACL by suturing stump and fixation to femoral footprint by anchors

Arm Title

Augmentation group

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Repair or Aumentation of partial ACL tear

Intervention Description

We will use repair technique in one grouo and Augmentation in the other group

Primary Outcome Measure Information:

Title

The main outcome is difference in IKDC scores between two groups of patients

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: younger than 15 and older than 50 y multiligament injury complete ACL tear failed ACL reconstruction or repair

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Mikhaeil, Resident

Phone

01289375910

mickelmikhaa5@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Abd-El Radi, Lecturer

Phone

01225338766

mradi@aun.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Abd-El Radi, Lecturer

Organizational Affiliation

Orthopaedic Department , Faculty of medicine, Assiut University

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

30398894

Citation

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.

Results Reference

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PubMed Identifier

28210653

Citation

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.

Results Reference

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PubMed Identifier

26015599

Citation

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.

Results Reference

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PubMed Identifier

29362147

Citation

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.

Results Reference

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Repair Versus Augmentation of Partial ACL Tear

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