Anterior Cruciate Ligament InjuriesPhase 2/3NCT04906538
Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
A Phase 2/3 study testing all- inside anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Injuries, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- all- inside anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Apr 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-35 years old.
- Patients will be diagnosed as ACL tear by the following:
- History of knee traumatic event. II. Clinical examination (ant. Drawer test, Lachman test and pivot shift test). III. Radiological evidence of ACL tear by MRI.
Who cannot join
- Other intra or extra articular knee injuries.
- Previous ACL surgery on the affected knee.
- Bilateral ACL injuries.
- Significant Articular surface injury.
- Medical comorbidities
- Patients with malalignment (genu varum. Genu valgum and Genu recurvatum)
- Neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. (2) Rate of complications and reoperation.
Read the detailed description
Investigators performed a randomized control trial in two groups utilizing All- inside ACLR. Group I was augmented by suture tape and Group 2 without suture tape augmentation. From October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all- inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace group). Demographic data (age, sex, side of injury, time since injury), manual assessment (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- all- inside anterior cruciate ligament reconstruction
- Keywords
- Rolimeter, ACLR, internal suture augmentation, IKDC score, Lysholm score
- 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.
all- inside anterior cruciate ligament reconstructionProcedure or surgery
all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique
| Study group | Role | What they receive |
|---|---|---|
| anterior cruciate ligament reconstruction with internal suture augmentation technique | Active comparator | This group will be operated by using all-inside ACLR technique with internal suture augmentation technique Receives: Procedure: all- inside anterior cruciate ligament reconstruction |
| anterior cruciate ligament reconstruction without internal suture augmentation technique | Active comparator | This group will be operated by using all-inside ACLR technique without internal suture augmentation technique Receives: Procedure: all- inside anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lachmeter examination
objective measurement of knee laxity
Measured: 9 months
Lysholm score
subjective knee functional score (0 - 100) score. 100 is better in function
Measured: 9 months
International Knee Documentation score (IKDC) score
subjective knee functional score (0 - 100) score. 100 is better in function
Measured: 9 months
Secondary outcomes (1)
knee ROM
post- operative knee ROM
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Sep 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed abdelaziz Ramadan, Ain Shams University
- Investigators
- Ahmed A Khater, MD, Principal investigator, Professor of orthopedic surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906538
- Sponsor's protocol ID
- FMASU MD 310 2018
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: study protocol and abstract
Publications
Sobhy MH, Khater AH, Hassan MR, El Shazly O. Do functional outcomes and cuff integrity correlate after single- versus double-row rotator cuff repair? A systematic review and meta-analysis study. Eur J Orthop Surg Traumatol. 2018 May;28(4):593-605. doi: 10.1007/s00590-018-2145-7. Epub 2018 Feb 13.
PubMed 29442181
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
- ClinicalTrials.gov ID
- NCT04906538
- Acronym / sponsor ID
- FMASU MD 310 2018
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Rolimeter, ACLR, internal suture augmentation, IKDC score, Lysholm score
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 May 2021 (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.
The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. (2) Rate of complications and reoperation.
Detailed description
Investigators performed a randomized control trial in two groups utilizing All- inside ACLR. Group I was augmented by suture tape and Group 2 without suture tape augmentation. From October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all- inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace group). Demographic data (age, sex, side of injury, time since injury), manual assessment (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| anterior cruciate ligament reconstruction with internal suture augmentation technique | Active comparator | Procedure: all- inside anterior cruciate ligament reconstructionThis group will be operated by using all-inside ACLR technique with internal suture augmentation technique |
| anterior cruciate ligament reconstruction without internal suture augmentation technique | Active comparator | Procedure: all- inside anterior cruciate ligament reconstructionThis group will be operated by using all-inside ACLR technique without internal suture augmentation technique |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-35 years old.
- Patients will be diagnosed as ACL tear by the following:
- History of knee traumatic event. II. Clinical examination (ant. Drawer test, Lachman test and pivot shift test). III. Radiological evidence of ACL tear by MRI.
Key exclusion criteria (7 listed)
- Other intra or extra articular knee injuries.
- Previous ACL surgery on the affected knee.
- Bilateral ACL injuries.
- Significant Articular surface injury.
- Medical comorbidities
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 |
|---|---|---|
| all- inside anterior cruciate ligament reconstructionall- inside anterior cruciate ligament reconstruction with internal suture augmentation technique | Procedure or surgery | anterior cruciate ligament reconstruction with internal suture augmentation technique, anterior cruciate ligament reconstruction without internal suture augmentation technique |
Primary outcome
Lachmeter examination
Time frame: 9 months
objective measurement of knee laxity
Lysholm score
Time frame: 9 months
subjective knee functional score (0 - 100) score. 100 is better in function
International Knee Documentation score (IKDC) score
Time frame: 9 months
subjective knee functional score (0 - 100) score. 100 is better in function
1 secondary outcome
knee ROM
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 29442181Sobhy MH, Khater AH, Hassan MR, El Shazly O. Do functional outcomes and cuff integrity correlate after single- versus double-row rotator cuff repair? A systematic review and meta-analysis study. Eur J Orthop Surg Traumatol. 2018 May;28(4):593-605. doi: 10.1007/s00590-018-2145-7. Epub 2018 Feb 13.
- Individual participant dataSharing planned: Undecided. study protocol and abstract
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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. This study is not recruiting at the moment.
Ahmed A Khater, MD principal investigator
Professor of orthopedic surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing all- inside anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Injuries, run by Ain Shams 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Jun 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lachmeter examination (time frame: 9 months). The study lists 3 primary outcomes in all. 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 NCT04906538, which also lists 1 linked publication.
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 2 Jun 2021.