Clinical trial NCT06430775: Exploring Prolonged AMR in ACL Reconstructed Patients
Official title: Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
ACL
ACL Injury
ACL Tear
Anterior Cruciate Ligament Reconstruction
Arthrogenic Muscle Inhibition
Arthrogenic Muscle Responses
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2024-05-28
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Voluntary quadriceps activation
timeFrame: 5 months post ACL reconstruction
measure: Quadriceps and hamstrings activity / cocontraction during jumping tasks
timeFrame: 5 months post ACL reconstruction
Secondary outcomes:
measure: Quadriceps strength
timeFrame: 5 months post ACL reconstruction
measure: Hamstrings strength
timeFrame: 5 months post ACL reconstruction
measure: Patient reported knee function
timeFrame: 5 months post ACL reconstruction
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta Hospital (Campus Brugsesteenweg)
state: West-Vlaanderen
Study officials:
References: