Clinical trial NCT05644275: The Influence of Demographic Parameters and ACL Injury on the Association Among Clinical, Functional and Biomechanical Parameters
Official title: MechBRACE - The Influence of Demographic Parameters and ACL Injury on the Association Among Clinical, Functional and Biomechanical Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament (ACL) Injury
Keywords: limb symmetry index (LSI)
muscle strength
single leg hop (SLH) distance
Leg symmetry index for SLH (LSISLH distance)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All parameters of patients after ACL injuries and healthy controls assessed in the Laboratory for Functional Biomechanics, University Hospital Basel in two prior projects will be included in this study. All data were collected in research projects that had ethical approval and participants signed informed consent forms for the respective research project:

* Comparison between augmented ACL repair and ACL reconstruction (RetroBRACE, EKNZ 2019-00491 and RetroBRACE II, EKNZ 2020-00551)
* Evaluating the relationship of in vivo ambulatory load and mechanosensitive cartilage biomarkers (MechSens, EKNZ 2019-01315)

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Peak value for SLH distance
timeFrame: one time assessment at baseline
measure: Leg symmetry index for SLH (LSISLH distance)
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Orthopedics and Traumatology
Study officials:
affiliation: University Hospital Basel, Clinic for Orthopedics and Traumatology
name: Christian Egloff, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: