Exploring Prolonged AMR in ACL Reconstructed Patients

NCT06430775 | Recruiting

• 2 other identifiers: G086223NONZ-2023-0365
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Quadriceps strength

  5 months post ACL reconstruction

• Hamstrings strength

  5 months post ACL reconstruction

• Patient reported knee function

  5 months post ACL reconstruction

Study Arms (1)

ACLR-patients

The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

AZ Delta Hospital (Campus Brugsesteenweg)

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Erik Witvrouw, prof. dr.

CONTACT

+32 9 332 2609; erik.witvrouw@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 28, 2024
• Study Start: October 15, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available after publication.

Locations

BE (1)