Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction

Recruiting

• Conditions: Anterior Cruciate Ligament Reconstruction

• Registration Number: NCT06185803
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

Observational, ambispective, longitudinal, monocentric, open cohort study of a population of adult patients operated on for ACL reconstruction and receiving postoperative follow-up.

Detailed Description

On a large population of adult patients operated on for anterior cruciate ligament reconstruction and followed over a 12-month period under standard medical practice conditions.

Primary objective: to investigate, six months after surgery, the presence of patellofemoral pain and to evaluate the factors predictive of the occurrence of such pain.

Secondary objectives:

* Evaluate the incidence of patellofemoral pain at 12 months.

* Compare the functional status of patients with and without patellofemoral pain at 6 and 12 months.

Study Timeline

• Study Start: 2023-07-27
• Status Verified: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-29
• Last Update Posted: 2023-12-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patient aged 18 or over
• Patient who has been informed of the research and does not object to data collection
• Patient who has undergone or is about to undergo ACL ligamentoplasty surgery
• Regularly followed-up patient for whom the data required by the protocol will be available in the medical record History of contralateral ACL rupture

Exclusion Criteria

• History of associated fracture
• History of multi-ligament reconstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterior patellofemoral pain	Month 6	The presence of anterior patellofemoral pain at 6 months post-op was the primary endpoint of the study.

Secondary Outcome Measures

Name	Time	Method
Subjective symptoms assessment	Month 12	The Kujala Anterior Knee Pain Scale (Kujala AKPS) is a questionnaire used to assess subjective symptoms such as functional limitations and anterior knee pain. It comprises 13 items: 6 concerning the patient's activities (walking, running, jumping, stairs, squatting, prolonged sitting), 7 concerning the patient's symptoms (lameness, unloading, swelling, maltracking of the patella, muscle atrophy, flexion deficit).; The score ranges from 0 (highly symptomatic patient) to 100 (asymptomatic patient). Patients with a score of 70 are considered to have moderate disability.
Subjective knee assessment	Month 12	The International Knee Documentation Committee Subjective Knee Form is a self-administered questionnaire divided into three sections (symptoms, sports activities, function).; Its score ranges from 0 (worst situation) to 100 (no restrictions on daily activities and sports, and no symptoms).
Returning to sport	Month 12	Returning to sport after anterior cruciate ligament (ACL) reconstruction requires optimal physical and psychological recovery. The Anterior Cruciate Ligament-Return-to-Sport after Injury (ACL-RSI) scale is the first tool to assess this psychological dimension.; It consists of 12 questions with answers rated from 0 to 10 on a simple numerical scale
Sporting and occupational physical activity assessment	Month 12	The Tegner activity-level scale is a scale of sporting and occupational physical activity: from 0 (occupational disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level).; The scale was originally developed to measure activity following knee injuries, and validated for monitoring ACL ruptures following ligamentoplasty.

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France