THE EFFECT OF RAMP LESION REPAIR ON RETURN TO SPORTS IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
Primary Purpose
ACL, Meniscus Lesion, Sport Injury
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
surgery
Sponsored by
About this trial
This is an interventional treatment trial for ACL focused on measuring ramp lesion, acl, return to sport
Eligibility Criteria
Inclusion Criteria:
- ACLR
- ACLR with RAMP lesion repair
- To complete the 9th month after surgery
- Home exercise program by physiotherapist after surgery
Exclusion Criteria:
- Additional pathologies requiring surgery other than anterior cruciate ligament and RAMP lesion
- Misalignment
- Other ligamentous lesions
- Cartilage pathologies
- Joint disorders
- History of surgery from the same knee
- Chronic inflammatory and rheumatological disease
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ramp lesion repair
Anterior cruriciate ligament reconstruction
Arm Description
Outcomes
Primary Outcome Measures
Return to Sports After Anterior Cruciate Ligament Injury Scale (ACL-RSI)
Secondary Outcome Measures
Full Information
NCT ID
NCT05048420
First Posted
September 1, 2021
Last Updated
September 9, 2021
Sponsor
Medipol University
1. Study Identification
Unique Protocol Identification Number
NCT05048420
Brief Title
THE EFFECT OF RAMP LESION REPAIR ON RETURN TO SPORTS IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
Official Title
THE EFFECT OF RAMP LESION REPAIR ON RETURN TO SPORTS IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose/reason of the research: The anterior cruciate ligament (ACL) is an important ligament in maintaining knee function. In patients with anterior cruciate ligament (ACL) injury, concomitant intra-articular lesions are usually seen. It has been reported that approximately 43% of all patients with ACL tears have associated lateral or medial meniscal injuries.
Injury associated with a tear of the meniscotibial ligament in the posterior horn of the medial meniscus is defined as a RAMP lesion. Because the RAMP lesion is located within the posteromedial "blind spot", it has historically been underdiagnosed.
It has been reported that 9-17% of all ACL tears have RAMP lesions. RAMP lesions have been found to increase the force on the ACL. Injury to the meniscotibial ligaments has been shown to increase rotational instability of the knee.
Based on the available literature, there is a discrepancy between authors regarding the repair of a RAMP lesion during an acute ACL surgery. In chronic ACL rupture, some authors have suggested that the RAMP lesion has a suitable biological environment for healing.
thinks. However, excessive mobility of the meniscocapsular junction has been reported in RAMP lesions during knee flexion and extension. It has been suggested that these lesions are different from other peripheral tears and are not suitable for spontaneous healing. It is suggested that meniscal RAMP lesion repair will be the most effective approach. Rehabilitation after repair of a RAMP lesion depends on whether the repair is performed concurrently with ACL surgery. When performed with an ACL surgery, the process is followed according to the ACL rehabilitation protocol.
Even if the functionality of the knee is fully restored in the post-ACL surgery period, not all patients can return to their previous level of sportive performance due to various psychological, social and physiological factors. In the literature, different information can be found as criteria for returning to sports after ACL surgery. The rate of returning to sports was reported as 65-88% in patients with ACL reconstruction, and 19-82% in patients who were followed conservatively. However, there are few studies with short- or long-term follow-up after the identification and treatment of RAMP lesions. Accordingly, our aim in this study is to comprehensively evaluate the return to sports of participants who have undergone isolated anterior cruciate ligament surgery and who have had simultaneous RAMP lesion repair with anterior cruciate ligament surgery.
This assessment will provide the opportunity to examine functional capacity, balance, psychological state, activity level and pain with different measurement methods.
Material and method of the research: The study will consist of 2 groups, including 12 participants who have undergone isolated ACL surgery and 12 participants who have had simultaneous RAMP lesion repair in Istanbul Medipol Mega Hospitals Complex Orthopedics and Traumatology Unit, with a total of 24 participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, Meniscus Lesion, Sport Injury
Keywords
ramp lesion, acl, return to sport
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramp lesion repair
Arm Type
Experimental
Arm Title
Anterior cruriciate ligament reconstruction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
ACL reconstruction and RAMP lesion repair
Primary Outcome Measure Information:
Title
Return to Sports After Anterior Cruciate Ligament Injury Scale (ACL-RSI)
Time Frame
9 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ACLR
ACLR with RAMP lesion repair
To complete the 9th month after surgery
Home exercise program by physiotherapist after surgery
Exclusion Criteria:
Additional pathologies requiring surgery other than anterior cruciate ligament and RAMP lesion
Misalignment
Other ligamentous lesions
Cartilage pathologies
Joint disorders
History of surgery from the same knee
Chronic inflammatory and rheumatological disease
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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THE EFFECT OF RAMP LESION REPAIR ON RETURN TO SPORTS IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
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