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Exploring Prolonged AMR in ACL Reconstructed Patients

U

University Ghent

Status

Enrolling

Conditions

ACL
Arthrogenic Muscle Inhibition
ACL Tear
Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Reconstruction
ACL Injury
Anterior Cruciate Ligament Rupture
Arthrogenic Muscle Responses

Study type

Observational

Funder types

Other

Identifiers

NCT06430775
G086223N
ONZ-2023-0365

Details and patient eligibility

About

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.

Enrollment

190 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

190 participants in 1 patient group

ACLR-patients
Description:
The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled.

Trial contacts and locations

1

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Central trial contact

Erik Witvrouw, prof. dr.

Data sourced from clinicaltrials.gov

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