The Influence of Demographic Parameters and ACL Injury on the Association Among Clinical, Functional and Biomechanical Parameters

This retrospective study aims at analysing demographics and clinical, functional and biomechanical outcomes in patients after ACL injury (conservative therapy and/or surgery) in patients of different ages and healthy controls. Demographics, as well as clinical, functional and biomechanical parameters were collected between 2019 and 2022 in two research projects approved by the Ethikkommission Nordwestschweiz (EKNZ 2019-00491, EKNZ 2019-01315, EKNZ 2020-00551). The primary research question analyzes if maximal SLH distance and LSISLH distance are related to the predictors age, sex, isokinetic muscle strength and the presence of injury.

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Key information

Conditions

Anterior Cruciate Ligament (ACL) Injury Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

About this study

Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. ACL reconstruction using auto- and allografts is still the gold-standard technique and widely used in the surgical treatment of ACL ruptures. Potential deficits in the affected leg are frequently evaluated using the limb symmetry index (LSI) calculated as performance affected side/performance unaffected side x 100. Several factors other than injury may influence single leg hop (SLH) distance and LSI such as sex, age, and muscle strength. This retrospective study aims at analysing demographics and clinical, functional and biomechanical outcomes in patients after ACL injury (conservative therapy and/or surgery) in patients of different ages and healthy controls. Demographics, as well as clinical, functional and biomechanical parameters were collected between 2019 and 2022 in two research projects approved by the Ethikkommission Nordwestschweiz (EKNZ 2019-00491, EKNZ 2019-01315, EKNZ 2020-00551)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients: 2-10 years since ACL injury
Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee

Exclusion criteria

Bilateral injury or previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months
Concomitant conditions that affect the mobility of the knee (e.g., neuromuscular diseases that affect lower limb movement, injury of the posterior cruciate ligament (PCL), more than one collateral ligament ruptured, fracture, luxation of the knee, tumorous disease, immunosuppressed patients)
Inability to give informed consent

Treatment and study plan

Data collection (demographic, clinical, functional and biomechanical outcomes in patients after ACL injury (conservative therapy and/or surgery) in patients of different ages and healthy controls)

Other

Analysis of existing data from previous research projects MechSens (EKNZ 2019-01315) and RetroBRACE I and II (EKNZ 2019-00491 and EKNZ 2020-00551) as descriptive statistics (mean, standard deviation, range) for all parameters (for female or male patients with ACL injury and healthy subjects).

Primary outcomes

Peak value for SLH distance

Time frame: one time assessment at baseline

Peak value for SLH distance (for female or male patients with ACL injury and healthy subjects). This test is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.
Leg symmetry index for SLH (LSISLH distance)

Time frame: one time assessment at baseline

Leg symmetry index for SLH (LSISLH distance) for healthy (non-dominant/dominant side*100) and for ACL injured (ACL injured/contralateral*100). Leg symmetry index (LSI) calculated as performance affected side/performance unaffected side x 100. A commonly regarded threshold for the LSI is 90%, corresponding to a 10% deficit, which is considered physiological.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

MechBRACE - The Influence of Demographic Parameters and ACL Injury on the Association Among Clinical, Functional and Biomechanical Parameters

Acronym: MechBRACE

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 9, 2022
Registry last updated: Feb 18, 2025

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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