Clinical trial NCT06631690: Effect of ACL Reconstruction in Biomechanical Properties of Ankle Joint Complex
Official title: Effect of ACL Reconstruction Using Peroneus Longus Versus Hamstring Autografts on Biomechanical Properties of Ankle Joint Complex
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Ankle Sprains
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 .

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Peak torque of plantarflexors and evertors (N.m)
timeFrame: preoperative /3 months / 6 months
measure: Star Excursion Balance Test distance (cm)
timeFrame: preoperative /3 months / 6 months
measure: Single leg stance time (sec)
timeFrame: preoperative /3 months / 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Lamyaa Kotb Elsayad, PHd
role: STUDY_DIRECTOR
References: