Anterior Cruciate Ligament ReconstructionSPEDALNCT06185803
Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of associated fracture
- History of multi-ligament reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- anterior cruciate ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior cruciate ligament reconstructionProcedure or surgery
anterior cruciate ligament reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior patellofemoral pain
The presence of anterior patellofemoral pain at 6 months post-op was the primary endpoint of the study.
Measured: Month 6
Secondary outcomes (8)
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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start27 Jul 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vivactis M2Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185803
- Sponsor's protocol ID
- 2021-12-026
- Acronym
- SPEDAL
- Status last verified
- Jun 2025
- First submitted
- 15 Dec 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction.
- ClinicalTrials.gov ID
- NCT06185803
- Acronym / sponsor ID
- SPEDAL / 2021-12-026
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Vivactis M2Research
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of associated fracture
- History of multi-ligament reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior cruciate ligament reconstructionanterior cruciate ligament reconstruction | Procedure or surgery | – |
Primary outcome
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.
8 secondary outcomes
Returning to sport
Time frame: Month 6
Returning to sport
Time frame: Month 12
Subjective knee assessment
Time frame: Month 6
Subjective knee assessment
Time frame: Month 12
Subjective symptoms assessment
Time frame: Month 6
Subjective symptoms assessment
Time frame: Month 12
Sporting and occupational physical activity assessment
Time frame: Month 6
Sporting and occupational physical activity assessment
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior patellofemoral pain (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.