Effect of ACL Reconstruction in Biomechanical Properties of Ankle Joint Complex

NCT ID: NCT06631690

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2024-12-10

Brief Summary

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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

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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

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Anterior Cruciate Ligament Tear Ankle Sprains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Peroneus longus autograft group

* 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

Group Type ACTIVE_COMPARATOR

Isokinetic and functional balance tests

Intervention Type OTHER

Isokinetic and functional balance tests

hamstring autograft group

* 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

Group Type ACTIVE_COMPARATOR

Isokinetic and functional balance tests

Intervention Type OTHER

Isokinetic and functional balance tests

Interventions

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Isokinetic and functional balance tests

Isokinetic and functional balance tests

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Lena Mahmoud Abo Alfotoh ELbadawy

Demonstrator of Department of Biomechanics Faculty of Physical Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lamyaa Kotb Elsayad, PHd

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Lena ElBadawy, Bachelor's degree

Role: CONTACT

01115563006 ext. 002

Lamyaa Kotb Elsayad, PHD

Role: CONTACT

0 109 536 6120 ext. 002

Facility Contacts

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Lena ElBadawy

Role: primary

01115563006

Other Identifiers

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P.T.REC/012/005015

Identifier Type: -

Identifier Source: org_study_id

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