Exploring Prolonged AMR in ACL Reconstructed Patients

Recruiting

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

• Registration Number: NCT06430775
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-15
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Voluntary quadriceps activation	5 months post ACL reconstruction	A torque-based isometric biodex measurement using the interpolated twitch technique.
Quadriceps and hamstrings activity / cocontraction during jumping tasks	5 months post ACL reconstruction	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.

Secondary Outcome Measures

Name	Time	Method
Patient reported knee function	5 months post ACL reconstruction	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.
Quadriceps strength	5 months post ACL reconstruction	Concentric and isokinetic Biodex measurements of the quadriceps strength
Hamstrings strength	5 months post ACL reconstruction	Concentric and isokinetic Biodex measurements of the quadriceps strength

Trial Locations

Locations (1)

AZ Delta Hospital (Campus Brugsesteenweg); 🇧🇪 Roeselare, West-Vlaanderen, Belgium