Anterior Cruciate Ligament InjuriesNCT06430775
Exploring Prolonged AMR in ACL Reconstructed Patients
An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- How many people
- 190 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2023to May 2026
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 18-40 years old.
- Having suffered an ACL rupture.
- Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
AZ Delta Hospital (Campus Brugsesteenweg)
Roeselare, West-Vlaanderen, 8800
Thomas Tampere, Dr., 051 23 63 70, sportr@azdelta.be
About this study
Official title: Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction
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:
- 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.
- 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.
- 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.
- 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.
Read more
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
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACLR-patients | The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary quadriceps activation
A torque-based isometric biodex measurement using the interpolated twitch technique.
Measured: 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.
Measured: 5 months post ACL reconstruction
Secondary outcomes (3)
Quadriceps strength
Concentric and isokinetic Biodex measurements of the quadriceps strength
Measured: 5 months post ACL reconstruction
Hamstrings strength
Concentric and isokinetic Biodex measurements of the quadriceps strength
Measured: 5 months post ACL reconstruction
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.
Measured: 5 months post ACL reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start15 Oct 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430775
- Sponsor's protocol ID
- G086223N
- Other IDs
- ONZ-2023-0365
- Status last verified
- Jun 2024
- First submitted
- 17 May 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06430775
- Acronym / sponsor ID
- G086223N
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, ACL, ACL Injury, ACL Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACLR-patients | – | –The participants to be studied will have an anterior cruciate ligament injury for which surgical treatment is scheduled. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 18-40 years old.
- Having suffered an ACL rupture.
- Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Voluntary quadriceps activation
Time frame: 5 months post ACL reconstruction
A torque-based isometric biodex measurement using the interpolated twitch technique.
Quadriceps and hamstrings activity / cocontraction during jumping tasks
Time frame: 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.
3 secondary outcomes
Quadriceps strength
Time frame: 5 months post ACL reconstruction
Hamstrings strength
Time frame: 5 months post ACL reconstruction
Patient reported knee function
Time frame: 5 months post ACL reconstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Yes. All collected IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik Witvrouw, prof. dr. (+32 9 332 2609, erik.witvrouw@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary quadriceps activation (time frame: 5 months post ACL reconstruction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.