Effect of ACL Reconstruction in Biomechanical Properties of Ankle Joint Complex

October 6, 2024 updated by: Lena Mahmoud Abo Alfotoh ELbadawy, Cairo University

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 .

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Other: Isokinetic and functional balance tests
Isokinetic and functional balance tests
Active Comparator: 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
Other: Isokinetic and functional balance tests
Isokinetic and functional balance tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative /3 months / 6 months
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.
preoperative /3 months / 6 months
Single leg stance time (sec)
Time Frame: preoperative /3 months / 6 months
The procedure will be repeated three times
preoperative /3 months / 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Lamyaa Kotb Elsayad, PHd, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Actual)

April 10, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

October 6, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 6, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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