NCT02511158

Brief Summary

In this study we will examine patients who have undergone anterior cruciate and/or posterior cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury, contralateral tear and functional outcomes at least two years after surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
320mo left

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress34%
Sep 2012Sep 2052

Study Start

First participant enrolled

September 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
17.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2032

Expected
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2052

Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

20 years

First QC Date

July 28, 2015

Last Update Submit

July 24, 2020

Conditions

Rupture of Anterior Cruciate LigamentOsteoarthritis

Keywords

Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament

Outcome Measures

Primary Outcomes (1)

  • Number of re-tear

    2 years

Secondary Outcomes (5)

  • International Knee Documentation Committee score

    2 years

  • Lyshom score

    2 years

  • Tegner score

    2 years

  • Knee injury and Osteoarthritis Outcome Score

    2 years

  • joint line space measurement on comparative standard radiograph at 30 degree of flexion before surgery and at the final follow-up (Schuss view)

    20 years

Interventions

Ligament of the knee reconstructionPROCEDURE

Reconstruction of ligaments of the knee by autografts

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants enrolled in the FAST cohort by one of four surgeons and meeting eligibility criteria

You may qualify if:

  • One ligament or multi-ligaments tear of the knee
  • Surgery reconstruction with any technique

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Médico-Chirurgical Paris V (CMCV)

Paris, 75005, France

RECRUITING

Related Publications (12)

  • Lefevre N, Klouche S, de Pamphilis O, Devaux C, Herman S, Bohu Y. Postoperative discomfort after outpatient anterior cruciate ligament reconstruction: a prospective comparative study. Orthop Traumatol Surg Res. 2015 Apr;101(2):163-6. doi: 10.1016/j.otsr.2014.07.036. Epub 2015 Feb 7.

    PMID: 25666422RESULT

  • Lefevre N, Bohu Y, de Pamphilis O, Klouche S, Devaux C, Herman S. Outpatient surgery feasibility in anterior cruciate ligament reconstruction: a prospective comparative assessment. Orthop Traumatol Surg Res. 2014 Sep;100(5):521-6. doi: 10.1016/j.otsr.2014.03.024. Epub 2014 Jul 28.

    PMID: 25082774RESULT

  • Bohu Y, Klouche S, Lefevre N, Webster K, Herman S. Translation, cross-cultural adaptation and validation of the French version of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1192-6. doi: 10.1007/s00167-014-2942-4. Epub 2014 Mar 28.

    PMID: 24676789RESULT

  • Lefevre N, Naouri JF, Bohu Y, Klouche S, Herman S. Sensitivity and specificity of bell-hammer tear as an indirect sign of partial anterior cruciate ligament rupture on magnetic resonance imaging. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1112-8. doi: 10.1007/s00167-013-2511-2. Epub 2013 Apr 21.

    PMID: 23604176RESULT

  • Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Validity of GNRB(R) arthrometer compared to Telos in the assessment of partial anterior cruciate ligament tears. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):285-90. doi: 10.1007/s00167-013-2384-4. Epub 2013 Jan 22.

    PMID: 23338663RESULT

  • Sadeqi M, Klouche S, Bohu Y, Herman S, Lefevre N, Gerometta A. Progression of the Psychological ACL-RSI Score and Return to Sport After Anterior Cruciate Ligament Reconstruction: A Prospective 2-Year Follow-up Study From the French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST). Orthop J Sports Med. 2018 Dec 17;6(12):2325967118812819. doi: 10.1177/2325967118812819. eCollection 2018 Dec.

    PMID: 30574516RESULT

  • Bohu Y, Klouche S, Herman S, de Pamphilis O, Gerometta A, Lefevre N. Professional Athletes Are Not at a Higher Risk of Infections After Anterior Cruciate Ligament Reconstruction: Incidence of Septic Arthritis, Additional Costs, and Clinical Outcomes From the French Prospective Anterior Cruciate Ligament Study (FAST) Cohort. Am J Sports Med. 2019 Jan;47(1):104-111. doi: 10.1177/0363546518810527. Epub 2018 Nov 27.

    PMID: 30481480RESULT

  • Raoul T, Klouche S, Guerrier B, El-Hariri B, Herman S, Gerometta A, Lefevre N, Bohu Y. Are athletes able to resume sport at six-month mean follow-up after anterior cruciate ligament reconstruction? Prospective functional and psychological assessment from the French Anterior Cruciate Ligament Study (FAST) cohort. Knee. 2019 Jan;26(1):155-164. doi: 10.1016/j.knee.2018.11.006. Epub 2018 Nov 22.

    PMID: 30473373RESULT

  • Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.

    PMID: 27720193RESULT

  • Lefevre N, Klouche S, Mirouse G, Herman S, Gerometta A, Bohu Y. Return to Sport After Primary and Revision Anterior Cruciate Ligament Reconstruction: A Prospective Comparative Study of 552 Patients From the FAST Cohort. Am J Sports Med. 2017 Jan;45(1):34-41. doi: 10.1177/0363546516660075. Epub 2016 Aug 20.

    PMID: 27530413RESULT

  • Moussa MK, Lefevre N, Valentin E, Coughlan A, Zgolli A, Gerometta A, Meyer A, Hardy A. Impact of Lateral Extra-Articular Procedure Augmentation on Rerupture Risk and Tegner Activity Scale Outcomes in Adolescent Anterior Cruciate Ligament: A Matched Comparative Study With a Minimum 2-Year Follow-up. Am J Sports Med. 2024 Mar;52(4):892-901. doi: 10.1177/03635465231223703. Epub 2024 Feb 9.

    PMID: 38333967DERIVED

  • Bohu Y, Klouche S, Sezer HB, Herman S, Grimaud O, Gerometta A, Meyer A, Lefevre N. Vancomycin-soaked autografts during ACL reconstruction reduce the risk of post-operative infection without affecting return to sport or knee function. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2578-2585. doi: 10.1007/s00167-020-05879-9. Epub 2020 Feb 5.

    PMID: 32025764DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesOsteoarthritis

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Shahnaz Klouche, MD

CONTACT

+33628350478klouche_shahnaz@yahoo.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician responsible of clinical research

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 29, 2015

Study Start

September 1, 2012

Primary Completion (Estimated)

September 1, 2032

Study Completion (Estimated)

September 1, 2052

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

FR(1)