## Protocol Section
### Identification Module
**NCT ID:** NCT06430775

**Brief Title:** Exploring Prolonged AMR in ACL Reconstructed Patients

**Official Title:** Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction

#### Organization Study ID Info
**ID:** G086223N
#### Organization
**Class:** OTHER
**Full Name:** University Ghent
#### Secondary ID Infos
**Domain:** Ethical committee Ghent University
**ID:** ONZ-2023-0365
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Research Foundation Flanders

#### Lead Sponsor

**Class:** OTHER

**Name:** University Ghent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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, 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.

### Conditions Module

**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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 190

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 5 Months

### Arms Interventions Module

#### Arm Group 1

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

**Label:** ACLR-patients

### Outcomes Module

#### Primary Outcomes

**Description:** A torque-based isometric biodex measurement using the interpolated twitch technique.

**Measure:** Voluntary quadriceps activation

**Time Frame:** 5 months post ACL reconstruction

**Description:** 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.

**Measure:** Quadriceps and hamstrings activity / cocontraction during jumping tasks

**Time Frame:** 5 months post ACL reconstruction

#### Secondary Outcomes

**Description:** Concentric and isokinetic Biodex measurements of the quadriceps and hamstrings strength.

**Measure:** Quadriceps and hamstrings strength

**Time Frame:** 5 months post ACL reconstruction

### Eligibility Module

**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.

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** erik.witvrouw@ugent.be

**Name:** Erik Witvrouw, prof. dr.

**Phone:** +32 9 332 2609

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Roeselare

**Contacts:**

***Contact 1:***

- **Email:** sportr@azdelta.be

- **Name:** Thomas Tampere, Dr.

- **Phone:** 051 23 63 70

- **Role:** CONTACT

**Country:** Belgium

**Facility:** AZ Delta Hospital (Campus Brugsesteenweg)

**State:** West-Vlaanderen

**Status:** RECRUITING

**Zip:** 8800

### IPD Sharing Statement Module

**Description:** All collected IPD that underlie results in a publication will be shared.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** The data will become available after publication.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007718

- Term: Knee Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M601

- Name: Anterior Cruciate Ligament Injuries

- Relevance: HIGH

- As Found: Anterior Cruciate Ligament Injuries

- ID: M15241

- Name: Rupture

- Relevance: HIGH

- As Found: Rupture

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M10738

- Name: Knee Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000012421

- Term: Rupture

- ID: D000070598

- Term: Anterior Cruciate Ligament Injuries

### Misc Info Module

- Version Holder: 2024-05-31
