NCT06185803

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jun 2026

Study Start

First participant enrolled

July 27, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

December 15, 2023

Last Update Submit

June 4, 2025

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Anterior patellofemoral pain

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

    Month 6

Secondary Outcomes (8)

  • Returning to sport

    Month 6

  • Returning to sport

    Month 12

  • Subjective knee assessment

    Month 6

  • Subjective knee assessment

    Month 12

  • Subjective symptoms assessment

    Month 6

  • +3 more secondary outcomes

Interventions

anterior cruciate ligament reconstructionPROCEDURE

anterior cruciate ligament reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • History of associated fracture
  • History of multi-ligament reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

MeSH Terms

Interventions

Anterior Cruciate Ligament Reconstruction

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 29, 2023

Study Start

July 27, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)