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Rupture of Anterior Cruciate LigamentFASTNCT02511158

French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)

An observational study of Rupture of Anterior Cruciate Ligament and Osteoarthritis, run by Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 7 years and older
What is being tested?
Ligament of the knee reconstruction
Type of treatment
Surgery or procedure
How many people
7,000 participants
Where
1 siteFrance
Study dates
Sep 2012to Sep 2052
How long will I take part?
20 Years
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 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patient refusal

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shahnaz Klouche, MD contact

+33628350478

klouche_shahnaz@yahoo.fr

France1 site, 1 recruiting

  • Centre Médico-Chirurgical Paris V (CMCV)

    Paris, 75005

    Shahnaz Klouche, MD, +628350478, klouche_shahnaz@yahoo.fr

    Serge Herman, MD

    Recruiting

Other trials in France

About this study

Official title: Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery

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.

Read the detailed description

The purpose of this study is to identify the rate of re tear two year after ligament reconstruction of the knee. The second objective is to assess the osteoarthritis of the knee at 20 years follow-up.

Being tested
Ligament of the knee reconstruction
Keywords
Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament
Medical subject headings
Anterior Cruciate Ligament Injuries, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ligament of the knee reconstructionProcedure or surgery

    Reconstruction of ligaments of the knee by autografts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of re-tear

    Measured: 2 years

Secondary outcomes (5)

  1. International Knee Documentation Committee score

    Measured: 2 years

  2. Lyshom score

    Measured: 2 years

  3. Tegner score

    Measured: 2 years

  4. Knee injury and Osteoarthritis Outcome Score

    Measured: 2 years

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

    Measured: 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2015 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2032 (estimated)
  4. Study completionSep 2052 (estimated)

Resources

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
Prospective
Enrolment
7,000 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02511158
Sponsor's protocol ID
CMC2012
Acronym
FAST
Status last verified
Jul 2020
First submitted
28 Jul 2015
Last updated
27 Jul 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25666422

  • 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.

    PubMed 25082774

  • 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.

    PubMed 24676789

  • 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.

    PubMed 23604176

  • 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.

    PubMed 23338663

  • 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.

    PubMed 30574516

  • 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.

    PubMed 30481480

  • 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.

    PubMed 30473373

  • 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.

    PubMed 27720193

  • 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.

    PubMed 27530413

  • Denis-Aubree P, Moussa M, Valentin E, Lefevre N, Meyer A, Noailles T, Hardy A. The Impact of Preoperative Anxiety on the Incidence of Arthrogenic Muscle Inhibition After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2026 Aug 7;14(8):23259671261462819. doi: 10.1177/23259671261462819. eCollection 2026 Aug.

    PubMed 42571181

  • 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.

    PubMed 38333967

  • 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.

    PubMed 32025764

Questions about this trial

What is this clinical trial studying?

An observational study of Rupture of Anterior Cruciate Ligament and Osteoarthritis, run by Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Jul 2020. 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?

Contact Shahnaz Klouche, MD (+33628350478, klouche_shahnaz@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of re-tear (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02511158, which also lists 13 linked publications.

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 27 Jul 2020.

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