NCT05048420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

September 1, 2021

Last Update Submit

September 9, 2021

Conditions

Keywords

ramp lesionaclreturn to sport

Outcome Measures

Primary Outcomes (1)

  • Return to Sports After Anterior Cruciate Ligament Injury Scale (ACL-RSI)

    9 months

Study Arms (2)

Ramp lesion repair

EXPERIMENTAL
Procedure: surgery

Anterior cruriciate ligament reconstruction

EXPERIMENTAL
Procedure: surgery

Interventions

surgeryPROCEDURE

ACL reconstruction and RAMP lesion repair

Anterior cruriciate ligament reconstructionRamp lesion repair

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ACLR
  • ACLR with RAMP lesion repair
  • To complete the 9th month after surgery
  • Home exercise program by physiotherapist after surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 17, 2021

Study Start

March 1, 2019

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations