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Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction

Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06185803
Acronym
SPEDAL
Enrollment
500
Registered
2023-12-29
Start date
2023-07-27
Completion date
2026-06-30
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction

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.

Interventions

PROCEDUREanterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction

Sponsors

Vivactis M2Research
CollaboratorINDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Returning to sportMonth 6Returning 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
Subjective knee assessmentMonth 6The 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).
Subjective symptoms assessmentMonth 6The 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.
Sporting and occupational physical activity assessmentMonth 6The 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026