ACL InjuryAugmentationNCT05391672
Augmentation of Partial Anterior Cruciate Ligament Tear: Early Results
A study testing we will do ACL augmentation surgery to the patients who have partial ACL tear in people with ACL Injury and ACL Augmentation, run by Assiut University at 1 site in Egypt.
Trial summary
Clinical evaluation for the patients with partial ACL tear who had ACL augmentation Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- ACL Injury, ACL Augmentation
- What is being tested?
- we will do ACL augmentation surgery to the patients who have partial ACL tear
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2022to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- younger than 15 and older than 50 y
- multiligament injury
- complete ACL tear
- failed ACL reconstruction or repair
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiyt University
Asyut
Mickel Mikhaa, resident, +201289375910, mickelmikhaa5@gmail.com
About this study
Clinical evaluation for the patients with partial ACL tear who had ACL augmentation
Read the detailed description
we will do a clinical evaluation depending mainly on IKDC score for patients with partial ACL tear who undergoing ACL augmentation surgery inside Assiut university hospital
- Conditions
- ACL Injury, ACL Augmentation
- Being tested
- we will do ACL augmentation surgery to the patients who have partial ACL tear
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
we will do ACL augmentation surgery to the patients who have partial ACL tearProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: we will do ACL augmentation surgery to the patients who have partial ACL tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start9 Jun 2022
- Primary completion19 Mar 2026 (estimated)
- Study completion19 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective case series study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Mikhaeil Attallah Gendy, Assiut University
- Investigators
- Mohamed Abd-El Radi, Lecturer, Study director, Orthopaedic Department , Faculty of medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391672
- Sponsor's protocol ID
- 17101888
- Acronym
- Augmentation
- Status last verified
- Dec 2025
- First submitted
- 21 May 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30398894Dallo 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.
PubMed 28210653Sabat 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.
PubMed 26015599Sharp 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.
PubMed 29362147
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Partial Anterior Cruciate Ligament Tear: Early Results
- ClinicalTrials.gov ID
- NCT05391672
- Acronym / sponsor ID
- Augmentation / 17101888
- Conditions
- ACL Injury, ACL Augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 19 Mar 2026 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical evaluation for the patients with partial ACL tear who had ACL augmentation
Detailed description
we will do a clinical evaluation depending mainly on IKDC score for patients with partial ACL tear who undergoing ACL augmentation surgery inside Assiut university hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective case series study
| Arm | Type | Receives |
|---|---|---|
| Augmentation group | Other | Procedure: we will do ACL augmentation surgery to the patients who have partial ACL tearWe 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 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- younger than 15 and older than 50 y
- multiligament injury
- complete ACL tear
- failed ACL reconstruction or repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| we will do ACL augmentation surgery to the patients who have partial ACL tearwe 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. | Procedure or surgery | Augmentation group |
Primary outcome
The main outcome is difference in IKDC scores between the patients
Time frame: Baseline
we will evaluate the clinical outcome post operative mainly according to the difference in IKDC score between the patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 30398894Gobbi 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.
- Background: PubMed 28210653Dallo 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.
- Background: PubMed 26015599Sabat 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.
- Background: PubMed 29362147Sharp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Abd-El Radi, Lecturer study director
Orthopaedic Department , Faculty of medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing we will do ACL augmentation surgery to the patients who have partial ACL tear in people with ACL Injury and ACL Augmentation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Mikhaeil, Resident (01289375910, mickelmikhaa5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main outcome is difference in IKDC scores between the patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391672, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.