Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After Primary Anterior Cruciate Ligament Reconstruction

Muscle Weakness Clinical Trial

— PREDICT-ACLv2  

Official title:

Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897970
• Other study ID #: PREDICT-ACLv2
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Knee Injuries
• Muscle Weakness
• Wounds and Injuries

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