Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430775
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-05-17
Brief Title:
Exploring Prolonged AMR in ACL Reconstructed Patients
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
Exploring Prolonged Arthrogenic Muscle Responses and Associated Factors After Anterior Cruciate Ligament Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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- andor 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
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- andor 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ONZ-2023-0365 | OTHER | Ethical committee Ghent University | None |