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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05897970
Other study ID # PREDICT-ACLv2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date May 1, 2023

Study information

Verified date June 2023
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anterior cruciate ligament (ACL) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. However, the risk of secondary severe knee injury is increased after ACLR, especially in athletes returning to strenuous activities. If strength symmetry is considered as an important factor in the Return-to-sport (RTS) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after ACLR. The main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after ACL-R.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 1, 2023
Est. primary completion date May 1, 2021
Accepts healthy volunteers
Gender All
Age group 16 Years to 55 Years
Eligibility Inclusion Criteria: Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 3-4 months Patient who received the information form Patients with access to the Internet Exclusion Criteria: Patient who did not participate in all follow-up consultations and isokinetic muscular assessments Patients who had a previous knee surgery before the ACLR Cognitive or sensory impairment making it impossible to understand the information form Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Return-to-sport (RTS) follow-up
All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017

Locations

Country Name City State
France CHU Caen Normandie Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Strength Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer. ACL group: Two evaluations on both injured and healthy knees: 3-4 months after surgery; Routine practice following guidelines]
Secondary Individual characteristics Personal characteristics recorded in the medical report as age, gender, type of sport and sport level of practice and return to sport after the surgery and severe reinjury on the operated knee or contralateral knee. ACLR group: Two follow-up medical consultations: (1) 4 months after surgery and (2) 2 years after the surgery for return to sport and reinjury;
Secondary Surgery characteristics Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration ACLR group: Two follow-up medical consultations 4 months after surgery
Secondary Re-injuries Web based questionnaire about any sever knee injury (meniscus or ACL) after the primary ACLR ACLR group: One evaluation with a minimum 2 years follow-up after the surgery
Secondary Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. Web based questionnaire with completion of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. ACLR group: One evaluation with a minimum 2 years follow-up after the surgery
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