Prolonged Preoperative Rehabilitation in ACL Rupture. (ISO-LCA-PREOP)

Strength Muscular Assessment and Prolonged Preoperative Rehabilitation Interest in the Anterior Cruciate Ligament Rupture - a Preliminary Study

Rupture of the anterior cruciate ligament is a serious and common injury. In young athletes, surgical reconstruction of the anterior cruciate ligament by autograft with hamstrings or patellar ligament is widely used.

Despite relatively standardized medical, surgical, and paramedical management, the results after ACL ligamentoplasty are not entirely satisfactory in term of return to sport. Recovery of the quadriceps strength is recognized as one of the decision-making criteria allowing the return to sport; however, significant muscle deficits are frequent at the time of return to sport.

If the postoperative management is well codified, focused on muscle strengthening and neuromuscular retraining, some studies have addressed the value of preoperative rehabilitation, and recommend a good preoperative muscular recovery of knee extensors and flexors, to obtain better postoperative results at the stage of the return to sports.

These results suggest that preoperative quadriceps strength should be considered as a predictor of the athletes' ability to return to sport activities.

It is estimated that around 10 to 30% of patients with preoperative deficits and could benefit from additional rehabilitation.

It can then be assumed that if the preoperative deficit is smaller, the postoperative deficit will also be smaller. This is the challenge of preoperative rehabilitation.

There are a few studies on preoperative rehabilitation which allow a gain in strength of knee extensors and flexors. However, the rehabilitation protocols applied to patients highly varied and there is no consensus on one protocol. The potential improvement is in the range of 10 to 20%.

The hypothesis of the study is that an optimal recovery of the strength of the preoperative knee extensors and flexors would reduce the postoperative deficit, thus improving the return to sport.

In the absence of reliable information on the frequency of muscle weakness in preoperative patients, we will conduct a preliminary study to obtain these data as well as the potential gain in strength with our preoperative rehabilitation protocol.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Device: Acute ACL injury

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Swynghedauw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Acute ACL injury (< 4 weeks) before surgical treatment
• Patient given written consent to participate in the study,
• Patient able to understand the protocol and willing to comply with its rules.
• Social security affiliated

Exclusion Criteria:

• Age < 18 years ou > 45 years,
• ACL rupture associated with fracture or complex meniscal tear or lesion to the lateral collateral ligament or posterior cruciate ligament
• History of ligament surgery on the affected and non-affected knee.
• fracture
• Isokinetic contraindications : cardiorespiratory, metabolic, neurological, cancer or hematological pathology contraindicating physical activity, long term steroid use (> 3 months), pregnancy, skin problems under load cell, osteoporosis, anticoagulants
• Patient under the protection of adults
• Informed consent not obtained

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1	Device: Acute ACL injury; Quantification of the preoperative deficits, by an isokinetic dynamometer, in order to adapt the care management of patients found with a muscle deficiency. Patients with preoperative knee extensor deficits > 15% will benefit from an additional preoperative rehabilitation protocol (8 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.	4-6 weeks after ACL injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.	through study completion, an average of 20 weeks
Functional testing : SEBT		4-6 weeks after ACL injury and through study completion, an average of 20 weeks
Title Questionnaires : Lyshom		4-6 weeks after ACL injury and through study completion, an average of 20 weeks
Title Questionnaires : confidence questionnaire		4-6 weeks after ACL injury and through study completion, an average of 20 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: André THEVENON, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; strength; preoperative; anterior cruciate ligament; isokinetic
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 2020_71; 2021-A00598-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No