French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)

Osteoarthritis Clinical Trial

— FAST  

Official title:

Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511158
• Other study ID #: CMC2012
• Status: Recruiting
• Start date: September 2012
• Est. completion date: September 2052

Study information

• Verified date: July 2020
• Source: Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport
• Contact: Shahnaz Klouche, MD
• Phone: +33628350478
• Email: klouche_shahnaz[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: September 2052
• Est. primary completion date: September 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• One ligament or multi-ligaments tear of the knee

• Surgery reconstruction with any technique

Exclusion Criteria:

• Patient refusal

Related Conditions & MeSH terms

• Osteoarthritis
• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
• Ligament of the knee reconstruction
Reconstruction of ligaments of the knee by autografts

Locations

Country	Name	City	State
France	Centre Médico-Chirurgical Paris V (CMCV)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

Country where clinical trial is conducted

France, 

References & Publications (10)

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 — View Citation

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 — View Citation

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 — View Citation

Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Validity of GNRB® 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. — View Citation

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.2 — View Citation

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-i — View Citation

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- — View Citation

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. — View Citation

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 — View Citation

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 Cr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of re-tear		2 years
Secondary	International Knee Documentation Committee score		2 years
Secondary	Lyshom score		2 years
Secondary	Tegner score		2 years
Secondary	Knee injury and Osteoarthritis Outcome Score		2 years
Secondary	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