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NCT Number: NCT06631690

Effect of ACL Reconstruction in 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 .

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 .

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Key information

Conditions

Anterior Cruciate Ligament Tear Ankle Injuries Ankle Sprains Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isokinetic and functional balance tests

Other

Isokinetic and functional balance tests

Primary outcomes

  1. 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

  2. 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.

  3. Single leg stance time (sec)

    Time frame: preoperative /3 months / 6 months

    The procedure will be repeated three times

Study contacts

Contact information is provided by the study sponsor or research team.

Lamyaa Kotb Elsayad, PHD

CONTACT

[email protected]

0 109 536 6120 ext. 002

Lena ElBadawy, Bachelor's degree

CONTACT

[email protected]

01115563006 ext. 002

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of ACL Reconstruction Using Peroneus Longus Versus Hamstring Autografts on Biomechanical Properties of Ankle Joint Complex

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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