NCT05270551

Brief Summary

The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started May 2026

Status
not yet 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

Study Progress6%
May 2026May 2027

First Submitted

Initial submission to the registry

February 14, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
4.2 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

February 14, 2022

Last Update Submit

April 28, 2026

Conditions

ACL Injury

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Clinical outcome

    Tegner Lysholm scores, which assesses activity levels

    1 year follow up

  • Clinical outcome

    International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities

    1 year follow up

Secondary Outcomes (1)

  • Radiological outcome

    6 months follow up

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Without augmentation

Procedure: ACL Reconstruction

Group 2

ACTIVE COMPARATOR

With augmentation

Procedure: ACL Reconstruction

Interventions

ACL ReconstructionPROCEDURE

All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Group 1Group 2

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.
  • With or without meniscal injury.
  • Isolated ACL injury without any other ligament injury.
  • Recent and chronic injury.

You may not qualify if:

  • Multiligament injury.
  • Deformed knee (Genu varus or valgus).
  • Previous ACL reconstruction or repair.
  • Older than 50 years old and younger than 15 years old.
  • Failed ACL reconstruction or repair -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Schlumberger M, Schuster P, Schulz M, Immendorfer M, Mayer P, Bartholoma J, Richter J. Traumatic graft rupture after primary and revision anterior cruciate ligament reconstruction: retrospective analysis of incidence and risk factors in 2915 cases. Knee Surg Sports Traumatol Arthrosc. 2017 May;25(5):1535-1541. doi: 10.1007/s00167-015-3699-0. Epub 2015 Sep 26.

    PMID: 26410092BACKGROUND

  • Riediger MD, Stride D, Coke SE, Kurz AZ, Duong A, Ayeni OR. ACL Reconstruction with Augmentation: a Scoping Review. Curr Rev Musculoskelet Med. 2019 Jun;12(2):166-172. doi: 10.1007/s12178-019-09548-4.

    PMID: 30945237BACKGROUND

  • Cristiani R, Mikkelsen C, Wange P, Olsson D, Stalman A, Engstrom B. Autograft type affects muscle strength and hop performance after ACL reconstruction. A randomised controlled trial comparing patellar tendon and hamstring tendon autografts with standard or accelerated rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3025-3036. doi: 10.1007/s00167-020-06334-5. Epub 2020 Oct 31.

    PMID: 33128587BACKGROUND

  • Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.

    PMID: 28224069BACKGROUND

  • Chmielewski TL, Jones D, Day T, Tillman SM, Lentz TA, George SZ. The association of pain and fear of movement/reinjury with function during anterior cruciate ligament reconstruction rehabilitation. J Orthop Sports Phys Ther. 2008 Dec;38(12):746-53. doi: 10.2519/jospt.2008.2887.

    PMID: 19047767BACKGROUND

  • Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. doi: 10.1177/0363546505279922.

    PMID: 16230470BACKGROUND

  • Dean AG. OpenEpi: open source epidemiologic statistics for public health, version 2.3. 1. http://www. openepi. com. 2010.

    BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Mohamed Abdel Hamid, Professor

    Mohamad Mohamed Abdel-Hamid Morsy

    STUDY CHAIR

  • Hatem Galal El-Din Zaki, Professor

    Hatem Galal El-Din Zaki

    PRINCIPAL INVESTIGATOR

  • Mohamed Abd El-Radi, Lecturer

    Mohamed Abd El-Radi Abd El-Salam

    STUDY DIRECTOR

Central Study Contacts

Mohamed Abdel Tawab, Master

CONTACT

+201022141998mohamedtawab8892@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 8, 2022

Study Start

May 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04