Exploring Prolonged AMR in ACL Reconstructed Patients

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430775
• Other study ID #: G086223N
• Secondary ID: ONZ-2023-0365
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University Ghent
• Contact: Erik Witvrouw, prof. dr.
• Phone: +32 9 332 2609
• Email: erik.witvrouw[@]ugent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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, isometrich 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL
• ACL Injury
• ACL Tear
• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Reconstruction
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture
• Wounds and Injuries

Locations

Country	Name	City	State
Belgium	AZ Delta Hospital (Campus Brugsesteenweg)	Roeselare	West-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voluntary quadriceps activation	A torque-based isometric biodex measurement using the interpolated twitch technique.	5 months post ACL reconstruction
Primary	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	Quadriceps strength	Concentric and isokinetic Biodex measurements of the quadriceps strength	5 months post ACL reconstruction
Secondary	Hamstrings strength	Concentric and isokinetic Biodex measurements of the quadriceps strength	5 months post ACL reconstruction
Secondary	Link between VA and Q:H CCI	Is there a link between the level of voluntary quadriceps activation and the Quadriceps-hamstrings co-contraction during jumps?	5 months post ACL reconstruction
Secondary	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