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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05644275
Acronym
MechBRACE
Enrollment
181
Registered
2022-12-09
Start date
2022-11-02
Completion date
2025-01-31
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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)

Interventions

OTHERData 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)

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).

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peak value for SLH distanceone time assessment at baselinePeak 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)one time assessment at baselineLeg 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026