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NCT Number: NCT06185803

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior cruciate ligament reconstruction

Procedure

anterior cruciate ligament reconstruction

Primary outcomes

  1. Anterior patellofemoral pain

    Time frame: Month 6

    The presence of anterior patellofemoral pain at 6 months post-op was the primary endpoint of the study.

Secondary outcomes

  1. Returning to sport

    Time frame: Month 6

    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

  2. Returning to sport

    Time frame: 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

  3. Subjective knee assessment

    Time frame: Month 6

    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).

  4. Subjective knee assessment

    Time frame: 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).

  5. Subjective symptoms assessment

    Time frame: Month 6

    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.

  6. Subjective symptoms assessment

    Time frame: 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.

  7. Sporting and occupational physical activity assessment

    Time frame: Month 6

    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.

  8. Sporting and occupational physical activity assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Vivactis M2Research

Registry information

Official study title

Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction.

Acronym: SPEDAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2023
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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