Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction (SPEDAL)

Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction.

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

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Procedure: anterior cruciate ligament reconstruction

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Recruiting
    • Clinique de la Sauvegarde
    • Contact: Guillaume DEMEY, MD; Phone Number: 33 04-37-49-66-77; Email: demeyguillaume@gmail.com
    • Principal Investigator: Guillaume DEMEY, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The inclusion population will be described according to all patient characteristics.

Quantitative variables will be described by their number, mean, standard deviation, median, extreme values and missing data. Qualitative variables will be described by their number, percentage and missing data. Bilateral 95% confidence intervals will be provided if the criterion is considered relevant.

The population will be described overall and in each group.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior patellofemoral pain	The presence of anterior patellofemoral pain at 6 months post-op was the primary endpoint of the study.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Returning to sport	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	Month 6
Returning to sport	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	Month 12
Subjective knee assessment	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).	Month 6
Subjective knee assessment	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).	Month 12
Subjective symptoms assessment	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.	Month 6
Subjective symptoms assessment	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.	Month 12
Sporting and occupational physical activity assessment	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.	Month 6
Sporting and occupational physical activity assessment	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.	Month 12

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Vivactis M2Research

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 2021-12-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No