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

NCT05644275 | Completed

• 1 other identifier: 2022-01851; mu22Egloff
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (2)

• Peak value for SLH distance

  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.

  one time assessment at baseline

• Leg symmetry index for SLH (LSISLH distance)

  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.

  one time assessment at baseline

Interventions

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).

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Data Collection; Demography; Functional Status

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Population Characteristics; Epidemiologic Measurements; Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status

Study Officials

• Christian Egloff, PD Dr. med.

  University Hospital Basel, Clinic for Orthopedics and Traumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: November 2, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CH (1)