Exploring Prolonged AMR in ACL Reconstructed Patients

Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction

The goal of this observational study is to explore the significance of subject-reported outcomes and clinical parameters in relation to the occurence of prolonged presence of arthrogenic muscle responses (AMR) in anterior cruciate ligament (ACL) reconstructed patients. The main questions it aims to answer are:

1. Is there a link between the long-term occurence of AMR in ACL reconstructed patients and the level of kinesiophobia experienced before or after their ACL surgery? We hypothesize that ACL patients with higher levels of kinesiophobia are more likely to exhibit prolonged AMR as an unconscious reaction to protect their affected knee joint.

2. Is the long-term presence of AMR in ACL reconstructed patients linked to their subjective knee function and stability (at certain time points throughout their recovery)? Our hypothesis is that poorer subjective knee function and stability might be associated with the presence of prolonged arthrogenic muscle responses in ACL reconstructed patients.

3. Is the prolonged presence of AMR in ACL reconstructed patients linked to their pain levels (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with higher pre- and/or postsurgical pain levels may exhibit a higher degree of long-lasting AMR.

4. Is the long-term presence of AMR in ACL reconstructed patients linked to clinical parameters such as swelling, isometric quadriceps and hamstrings strength and knee range of motion (at certain time points throughout their recovery)? Our hypothesis is that ACL patients with poorer outcomes in terms of these clinical parameters may be more likely to exhibit prolonged AMR.

Participants will:

• Fill in the following questionnaires 1 week before surgery and at 1 and 3 months after surgery:

  • Demopgraphical information
  • Knee Injury and Osteoarthritis Outcome Score (KOOS)
  • Lysholm Score (only question 1)
  • Tegner Activity Scale (current activity level, pre-injury activity level and desired activity level after recovery)
  • Numeric Rating Score (NRS) for pain levels during the day & during the night
  • ACL-Return to Sport after Injury Scale (ACL-RSI)
• Complete a testing protocol 5 months after their surgery, which includes bilateral electromyographical measurements of the hamstrings and quadriceps during jumping tasks and a quadriceps inhibition measurement using the interpolated twitch method to evaluate the presence of prolonged AMR.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Reconstruction; ACL; ACL Injury; ACL Tear; Arthrogenic Muscle Inhibition; Arthrogenic Muscle Responses

• Study Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: Erik Witvrouw, prof. dr.; Phone Number: +32 9 332 2609; Email: erik.witvrouw@ugent.be

Study Locations

• Belgium
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Recruiting
      • AZ Delta Hospital (Campus Brugsesteenweg)
      • Contact: Thomas Tampere, Dr.; Phone Number: 051 23 63 70; Email: sportr@azdelta.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged between 18 and 40 who have suffered an ACL rupture and for whom ACL reconstructive surgery is planned at AZ Delta Hospital in Roeselare.

Description

Inclusion Criteria:

• 18-40 years old.
• Having suffered an ACL rupture.
• Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).

Exclusion Criteria:

• Revision ACL reconstruction.
• Other severe injuries to the lower limbs within the past year.
• Muscular or neurological disorders affecting lower limb functioning.
• Fibromyalgia or chronic fatigue syndrome.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ACLR-patients; The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voluntary quadriceps activation	A torque-based isometric biodex measurement using the interpolated twitch technique.	5 months post ACL reconstruction
Quadriceps and hamstrings activity / cocontraction during jumping tasks	Electromyographical measurement of quadriceps and hamstrings activation during jumping tasks: bilateral countermovement jump, unilateral countermovement jump and unilateral vertical drop jump with a 90° medial turn. The cocontraction will be quantified with cocontraction indices.	5 months post ACL reconstruction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps strength	Concentric and isokinetic Biodex measurements of the quadriceps strength	5 months post ACL reconstruction
Hamstrings strength	Concentric and isokinetic Biodex measurements of the quadriceps strength	5 months post ACL reconstruction
Patient reported knee function	Questioned using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores on the KOOS range from 0-100, with 0 representing the greatest possible problems in terms of knee function and 100 representing no problems.	5 months post ACL reconstruction

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: G086223N; ONZ-2023-0365 (Ethical committee Ghent University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD that underlie results in a publication will be shared.
• IPD Sharing Time Frame: The data will become available after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No