Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

— SPEDAL  

Official title:

Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185803
• Other study ID #: 2021-12-026
• Status: Recruiting
• Start date: July 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Patellofemoral Pain Syndrome

Intervention

Procedure:
• anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche	Vivactis M2Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior patellofemoral pain	The presence of anterior patellofemoral pain at 6 months post-op was the primary endpoint of the study.	Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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