ACL - Anterior Cruciate Ligament DeficiencyNCT05817084
Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.
A study testing medial opening wedge high tibial osteotomy and anterior cruciate ligament reconstruction in people with ACL - Anterior Cruciate Ligament Deficiency and Varus Deformity of Tibia (Disorder), run by Mostafa Hassanein, Msc at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Deficiency, Varus Deformity of Tibia (Disorder), ACL Injury
- What is being tested?
- medial opening wedge high tibial osteotomy and anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Mar 2024
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 50.
- Knee varus malalignment 7-10°.
- ACL injury with clinical anterior instability confirmed by MRI.
Who cannot join
- Osteoarthritis (Kellgren-Lawrence grade IV).
- Inflammatory joint disease.
- Knee flexion < 120°
- Knee fixed flexion deformity > 10°.
- BMI >30
- Any ligamentous or meniscal knee injury other than ACL injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study
The purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.
- Conditions
- ACL - Anterior Cruciate Ligament Deficiency, Varus Deformity of Tibia (Disorder), ACL Injury, Knee Deformity
- Being tested
- medial opening wedge high tibial osteotomy, anterior cruciate ligament reconstruction
- 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.
medial opening wedge high tibial osteotomyProcedure or surgery
medial opening wedge valgus high tibial osteotomy
anterior cruciate ligament reconstructionProcedure or surgery
anterior cruciate ligament reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto | Active comparator | anterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session Receives: Procedure: medial opening wedge high tibial osteotomy; Procedure: anterior cruciate ligament reconstruction |
| 12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction | Active comparator | anterior cruciate ligament reconstruction alone. Receives: Procedure: anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm knee score
knee score from 0 to 100 where a higher score means better outcome.
Measured: 1 month post operative
Lysholm knee score
knee score from 0 to 100 where a higher score means better outcome.
Measured: 3 month post operative
Lysholm knee score
knee score from 0 to 100 where a higher score means better outcome.
Measured: 6 month post operative
Tegner activity level
activity level from 0 to 11 where 11 means highest level
Measured: 1 month post operative
Tegner activity level
activity level from 0 to 11 where 11 means highest level
Measured: 3 months post operative
Tegner activity level
activity level from 0 to 11 where 11 means highest level
Measured: 6 months post operative
Return to pre injury level
time needed by the patient in months post operative to return to pre injury activity level
Measured: through study completion, an average of 7 months
Secondary outcomes (2)
knee range of motion
measure knee range of motion in degrees "flexion and extension"
Measured: pre operative, 1 month, 3months, and 6 months post operative
knee stability
Lachman knee stability test
Measured: pre operative, 1 month, 3months, and 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament DeficiencyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Hassanein, Msc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Hassanein, Msc, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817084
- Sponsor's protocol ID
- FMASU MD80/2022
- Status last verified
- Jul 2024
- First submitted
- 10 Mar 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Anterior Cruciate Ligament Reconstruction With and Without High Tibial Osteotomy in Knees With Varus Malalignment. Comparative Study
- ClinicalTrials.gov ID
- NCT05817084
- Acronym / sponsor ID
- FMASU MD80/2022
- Conditions
- ACL - Anterior Cruciate Ligament Deficiency, Varus Deformity of Tibia (Disorder), ACL Injury, Knee Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mostafa Hassanein, MscUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 18 Apr 2023 (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 to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. Evaluation will be clinically, radiologically and time needed to return to pre injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto | Active comparator | Procedure: medial opening wedge high tibial osteotomy, Procedure: anterior cruciate ligament reconstructionanterior cruciate ligament reconstruction and medial opening wedge high tibial osteotomy in the same session |
| 12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction | Active comparator | Procedure: anterior cruciate ligament reconstructionanterior cruciate ligament reconstruction alone. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 50.
- Knee varus malalignment 7-10°.
- ACL injury with clinical anterior instability confirmed by MRI.
Key exclusion criteria (6 listed)
- Osteoarthritis (Kellgren-Lawrence grade IV).
- Inflammatory joint disease.
- Knee flexion < 120°
- Knee fixed flexion deformity > 10°.
- BMI >30
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 |
|---|---|---|
| medial opening wedge high tibial osteotomymedial opening wedge valgus high tibial osteotomy | Procedure or surgery | 12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto |
| anterior cruciate ligament reconstructionanterior cruciate ligament reconstruction | Procedure or surgery | 12 patients with varus knee malalignment and acl deficiency under went acl reconstruction and hto, 12 patients with varus knee malalignment and acl deficiency underwent acl reconstruction |
Primary outcome
Lysholm knee score
Time frame: 1 month post operative
knee score from 0 to 100 where a higher score means better outcome.
Lysholm knee score
Time frame: 3 month post operative
knee score from 0 to 100 where a higher score means better outcome.
Lysholm knee score
Time frame: 6 month post operative
knee score from 0 to 100 where a higher score means better outcome.
Tegner activity level
Time frame: 1 month post operative
activity level from 0 to 11 where 11 means highest level
Tegner activity level
Time frame: 3 months post operative
activity level from 0 to 11 where 11 means highest level
Tegner activity level
Time frame: 6 months post operative
activity level from 0 to 11 where 11 means highest level
Return to pre injury level
Time frame: through study completion, an average of 7 months
time needed by the patient in months post operative to return to pre injury activity level
2 secondary outcomes
knee range of motion
Time frame: pre operative, 1 month, 3months, and 6 months post operative
knee stability
Time frame: pre operative, 1 month, 3months, and 6 months post operative
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 8 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for ACL - Anterior Cruciate Ligament Deficiency
Not yet recruitingObservational study
AI-Based Video Assessment of Anterior Knee Laxity
ACL - Anterior Cruciate Ligament Deficiency
RecruitingObservational study
5 Years' Follow-up Assessment of Surgical Repair for ACL Proximal Rupture
ACL - Anterior Cruciate Ligament Deficiency
RecruitingObservational study
Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
ACL - Anterior Cruciate Ligament Deficiency
Not yet recruitingObservational study
Measuring Knee Laxity and Pivot Shift in ACL-Deficient Patients
Anterior Cruciate Ligament (ACL) Tear
Not yet recruiting
ACLR: Isolated Autograft vs Allograft With Lateral Extra-articular Tenodesis
ACL Deficient Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medial opening wedge high tibial osteotomy and anterior cruciate ligament reconstruction in people with ACL - Anterior Cruciate Ligament Deficiency and Varus Deformity of Tibia (Disorder), run by Mostafa Hassanein, Msc 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 6 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 8 Jul 2024. 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?
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?
Lysholm knee score (time frame: 1 month post operative). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2024.