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

February 15, 2024 updated by: University Hospital, Basel, Switzerland

MechBRACE - 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Estimated)

186

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

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Orthopedics and Traumatology
        • Contact:
        • Principal Investigator:
          • Christian Egloff, PD Dr. med.
        • Contact:

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

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

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)

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one time assessment at baseline
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.
one time assessment at baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christian Egloff, PD Dr. med., University Hospital Basel, Clinic for Orthopedics and Traumatology

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)

November 2, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01851; mu22Egloff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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