THE EFFECT OF RAMP LESION REPAIR ON RETURN TO SPORTS IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

NCT ID: NCT05048420

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ACL Meniscus Lesion Sport Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ramp lesion repair

Group Type EXPERIMENTAL

surgery

Intervention Type PROCEDURE

ACL reconstruction and RAMP lesion repair

Anterior cruriciate ligament reconstruction

Group Type EXPERIMENTAL

surgery

Intervention Type PROCEDURE

ACL reconstruction and RAMP lesion repair

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

surgery

ACL reconstruction and RAMP lesion repair

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medipol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emre DANSUK

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MedipolUni

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.