Anterior Cruciate Ligament TearNCT06631690
Effect of ACL Reconstruction in Biomechanical Properties of Ankle Joint Complex
A study testing Isokinetic and functional balance tests in people with Anterior Cruciate Ligament Tear and Ankle Sprains, run by Cairo University at 1 site in Egypt.
Trial summary
BACKGROUND: Anterior cruciate ligament (ACL) is an important ligamentous structure in the knee joint which contributes in maintaining stability. ACL injury contribute to approximately 50% of knee injuries .The incidence of ACL ruptures is estimated to be between 30 and 78 per 100,000 people per year . Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Ankle Sprains
- What is being tested?
- Isokinetic and functional balance tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2024to 15 Jan 2026
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ranging between 15- 45 years
- Having unilateral isolated ACL tear with no concomitant tear of other ligaments of the knee
- Having no evidence of meniscal repair
- Having bilateral healthy ankle before surgery.
Who cannot join
- Pre-existing ankle injury or ankle instability
- Associated ligament injury, chondral damage, meniscal injury, fracture around the knee, and presence of pathologic condition in the lower extremity or an abnormal contralateral knee joint.
- Visible mal-alignments in the lower extremities.
- Previous surgery to the affected knee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of ACL Reconstruction Using Peroneus Longus Versus Hamstring Autografts on Biomechanical Properties of Ankle Joint Complex
BACKGROUND:
Anterior cruciate ligament (ACL) is an important ligamentous structure in the knee joint which contributes in maintaining stability. ACL injury contribute to approximately 50% of knee injuries .The incidence of ACL ruptures is estimated to be between 30 and 78 per 100,000 people per year .
Read more
The incidence of ACL ruptures varies depending on a number of factors, including age, sex, sport participation, and genetics. ACL ruptures are most common in young adults, particularly women. The risk of an ACL rupture has been reported as 2-8 times higher for women than for men. A systematic review study found that the risk of ACL injury was highest in football, followed by soccer, basketball, and skiing .
Nowadays, Peroneus longus tendon (PLT) autograft is used in orthopaedic surgeries. Some studies reported that PLT graft had maintained a possible more efficient ACL substitute for its tensile strength and regeneration ability after being inserted post-surgery . The PLT graft has additional benefit as it does not cause secondary injury to the knee and its adjacent structures .
Ankle proprioception is one of the crucial components contributing to postural control . PLT graft for ACL reconstruction might affect the already compromised body balance by influencing postural stability and ankle stability at the donor ankle site. So, this study will be conducted to assess and compare the effect of ACLreconstruction with PLT graft to the effect of ACL reconstruction with HT graft on ankle stability and postural control .
Read the detailed description
PURPOSE
- To assess the effect of ACL reconstruction with Peroneus longus tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
- To assess the effect of ACL reconstruction with Hamstring tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
- To compare between the effect of ACL reconstruction with Peroneus longus tendon autograft to ACL reconstruction with Hamstring tendon autograft on peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
HYPOTHESES
- There will be no significant effect of ACL reconstruction with Peroneus longus tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
- There will be no significant effect of ACL reconstruction with Hamstring tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score In patients with ACL reconstruction.
- There will be no significant difference in Peak torque of ankle plantarflexors and evertors , Single Leg Stance Test time and Star Excursion Balance Test score between ACL reconstruction with Peroneus longus tendon autograft and ACL reconstruction with Hamstring tendon autograft.
RESEARCH QUESTION::
- Will there be any effect of ACL reconstruction with Peroneus longus tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction?
- Will there be any effect of ACL reconstruction with Hamstring tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction ?
- Will there be any difference in Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score between ACL reconstruction with Peroneus longus tendon autograft and ACL reconstruction with Hamstring tendon autograft?
- Conditions
- Anterior Cruciate Ligament Tear, Ankle Sprains
- Being tested
- Isokinetic and functional balance tests
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic and functional balance testsOther
Isokinetic and functional balance tests
| Study group | Role | What they receive |
|---|---|---|
| Peroneus longus autograft group | Active comparator | * Isokinetic dynamometer is a three multi-joint testing and rehabilitation device. It will be used to measure concentric peak torques of ankle planter flexor and eccentric peak torque of evertor
* The modified Star Excursion Balance Test will be used to evaluate the dynamic balance with a series of unilateral balance tests
* Single leg Stance (SLS) test to assess balance, especially when performed in a static position Receives: Other: Isokinetic and functional balance tests |
| hamstring autograft group | Active comparator | * Isokinetic dynamometer is a three multi-joint testing and rehabilitation device. It will be used to measure concentric peak torques of ankle planter flexor and eccentric peak torque of evertor
* The modified Star Excursion Balance Test will be used to evaluate the dynamic balance with a series of unilateral balance tests
* Single leg Stance (SLS) test to assess balance, especially when performed in a static position Receives: Other: Isokinetic and functional balance tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak torque of plantarflexors and evertors (N.m)
The isokinetic strength of ankle muscles will be evaluated at angular velocities of 30°/s and 120°/s in concentric/concentric mode for the ankle Planter flexion/dorsiflexion and in concentric/eccentric reciprocal action for the ankle eversion/eversion
Measured: preoperative /3 months / 6 months
Star Excursion Balance Test distance (cm)
The Modified version of the Star Excursion Balance Test with only three directions (anterior, posterolateral [PL], and posteromedial [PM]) will be used .
The patient will be given four practice trials to familiarize themselves with the task, followed by a brief rest. Then, three trials will be recorded with at least 10 seconds of rest between each trial. The average of the three trials will be normalized to the participant's leg length and used for analysis.
Measured: preoperative /3 months / 6 months
Single leg stance time (sec)
The procedure will be repeated three times
Measured: preoperative /3 months / 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start10 May 2024
- Primary completion1 Nov 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Mahmoud Abo Alfotoh ELbadawy, Cairo University
- Investigators
- Lamyaa Kotb Elsayad, PHd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631690
- Sponsor's protocol ID
- P.T.REC/012/005015
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ACL Reconstruction Using Peroneus Longus Versus Hamstring Autografts on Biomechanical Properties of Ankle Joint Complex
- ClinicalTrials.gov ID
- NCT06631690
- Acronym / sponsor ID
- P.T.REC/012/005015
- Conditions
- Anterior Cruciate Ligament Tear, Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 8 Oct 2024 (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.
BACKGROUND:
Anterior cruciate ligament (ACL) is an important ligamentous structure in the knee joint which contributes in maintaining stability. ACL injury contribute to approximately 50% of knee injuries .The incidence of ACL ruptures is estimated to be between 30 and 78 per 100,000 people per year .
The incidence of ACL ruptures varies depending on a number of factors, including age, sex, sport participation, and genetics. ACL ruptures are most common in young adults, particularly women. The risk of an ACL rupture has been reported as 2-8 times higher for women than for men. A systematic review study found that the risk of ACL injury was highest in football, followed by soccer, basketball, and skiing .
Nowadays, Peroneus longus tendon (PLT) autograft is used in orthopaedic surgeries. Some studies reported that PLT graft had maintained a possible more efficient ACL substitute for its tensile strength and regeneration ability after being inserted post-surgery . The PLT graft has additional benefit as it does not cause secondary injury to the knee and its adjacent structures .
Ankle proprioception is one of the crucial components contributing to postural control . PLT graft for ACL reconstruction might affect the already compromised body balance by influencing postural stability and ankle stability at the donor ankle site. So, this study will be conducted to assess and compare the effect of ACLreconstruction with PLT graft to the effect of ACL reconstruction with HT graft on ankle stability and postural control .
Detailed description
PURPOSE
- To assess the effect of ACL reconstruction with Peroneus longus tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
- To assess the effect of ACL reconstruction with Hamstring tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
- To compare between the effect of ACL reconstruction with Peroneus longus tendon autograft to ACL reconstruction with Hamstring tendon autograft on peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
HYPOTHESES
- There will be no significant effect of ACL reconstruction with Peroneus longus tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction.
- There will be no significant effect of ACL reconstruction with Hamstring tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score In patients with ACL reconstruction.
- There will be no significant difference in Peak torque of ankle plantarflexors and evertors , Single Leg Stance Test time and Star Excursion Balance Test score between ACL reconstruction with Peroneus longus tendon autograft and ACL reconstruction with Hamstring tendon autograft.
RESEARCH QUESTION::
- Will there be any effect of ACL reconstruction with Peroneus longus tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction?
- Will there be any effect of ACL reconstruction with Hamstring tendon autograft on Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score in patients with ACL reconstruction ?
- Will there be any difference in Peak torque of ankle plantarflexors and evertors , Single Leg Stance test time and Star Excursion Balance Test score between ACL reconstruction with Peroneus longus tendon autograft and ACL reconstruction with Hamstring tendon autograft?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peroneus longus autograft group | Active comparator | Other: Isokinetic and functional balance tests* Isokinetic dynamometer is a three multi-joint testing and rehabilitation device. It will be used to measure concentric peak torques of ankle planter flexor and eccentric peak torque of evertor * The modified Star Excursion Balance Test will be used to evaluate the dynamic balance with a series of unilateral balance tests * Single leg Stance (SLS) test to assess balance, especially when performed in a static position |
| hamstring autograft group | Active comparator | Other: Isokinetic and functional balance tests* Isokinetic dynamometer is a three multi-joint testing and rehabilitation device. It will be used to measure concentric peak torques of ankle planter flexor and eccentric peak torque of evertor * The modified Star Excursion Balance Test will be used to evaluate the dynamic balance with a series of unilateral balance tests * Single leg Stance (SLS) test to assess balance, especially when performed in a static position |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ranging between 15- 45 years
- Having unilateral isolated ACL tear with no concomitant tear of other ligaments of the knee
- Having no evidence of meniscal repair
- Having bilateral healthy ankle before surgery.
Key exclusion criteria (4 listed)
- Pre-existing ankle injury or ankle instability
- Associated ligament injury, chondral damage, meniscal injury, fracture around the knee, and presence of pathologic condition in the lower extremity or an abnormal contralateral knee joint.
- Visible mal-alignments in the lower extremities.
- Previous surgery to the affected knee.
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 |
|---|---|---|
| Isokinetic and functional balance testsIsokinetic and functional balance tests | Other | Peroneus longus autograft group, hamstring autograft group |
Primary outcome
Peak torque of plantarflexors and evertors (N.m)
Time frame: preoperative /3 months / 6 months
The isokinetic strength of ankle muscles will be evaluated at angular velocities of 30°/s and 120°/s in concentric/concentric mode for the ankle Planter flexion/dorsiflexion and in concentric/eccentric reciprocal action for the ankle eversion/eversion
Star Excursion Balance Test distance (cm)
Time frame: preoperative /3 months / 6 months
The Modified version of the Star Excursion Balance Test with only three directions (anterior, posterolateral [PL], and posteromedial [PM]) will be used . The patient will be given four practice trials to familiarize themselves with the task, followed by a brief rest. Then, three trials will be recorded with at least 10 seconds of rest between each trial. The average of the three trials will be normalized to the participant's leg length and used for analysis.
Single leg stance time (sec)
Time frame: preoperative /3 months / 6 months
The procedure will be repeated three times
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 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lamyaa Kotb Elsayad, PHd study director
Cairo 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 Isokinetic and functional balance tests in people with Anterior Cruciate Ligament Tear and Ankle Sprains, run by Cairo 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 4 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: finished, as of the sponsor's last update on 26 Oct 2026. 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?
Peak torque of plantarflexors and evertors (N.m) (time frame: preoperative /3 months / 6 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?
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 26 Oct 2026.