Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear

NCT06178484 | Unknown

• 1 other identifier: RGDS-2022-12-063
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Isolated ruptures of the anterior cruciate ligament (ACL) can be proximal, distal or occur in the middle of the ACL. Treatment of patients with proximal lesions should be graded. Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and the risk of progression to a knee functionally unstable less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment. Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.

Conditions

ACL - Anterior Cruciate Ligament Deficiency

Outcome Measures

Primary Outcomes (1)

• Subjective IKDC (International Knee Documentation Committee) score

  Subjective IKDC score is based on 10 questions linded to knee status. This score is ranging from 0 to 100. 100 means a level of sport activity and daily activity without any limit in the absence of any symptoms.

  1 day

Study Arms (2)

Functional treatment

Functional treatment combines the use of splints, rehabilitation and muscle strengthening

Surgical treatment

Surgical treatment means ACL tear repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ACL tear treated with functional or surgery treatment

You may qualify if:

• Patient, male or female, aged ≥ 18 years
• Patient with no history of knee surgery except meniscal surgery
• Patient whose period is less than 3 months between the date of the accident and the surgery
• Patient with an isolated proximal Sherman 1 or 2 ACL tear
• Patient with a proximal Sherman 1 or 2 ACL tear associated to a stable meniscal lesion or to an MCL or LCL lesion grade 1 or 2 but not grade 3
• Patient practicing a non-contact pivot sport (sliding sports, board sports,racket)

You may not qualify if:

• Patient with contralateral ACL tear
• Patient practicing a pivot sport with contacts
• Patient presenting external rotary jumps ++ and +++
• Patient with an ACL tear Sherman 3 or 4
• Patient with meniscal lesions in the shape of a bucket handle or tabs unstable meniscals
• Patient with a surgical history on the knee concerned

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé La Louvière

Lille, Choisir Une Région, 59800, France

RECRUITING

Central Study Contacts

Romain LETARTRE, MD

CONTACT

+ 33 3 20 55 70 00; romainletartre@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)