Skip to main content
OpenTrials
Completed

NCT Number: NCT04888052

Prolonged Preoperative Rehabilitation in ACL Rupture.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Swynghedauw

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute ACL injury

Device

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).

Primary outcomes

  1. Muscle strength

    Time frame: 4-6 weeks after ACL injury

    Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.

Secondary outcomes

  1. Muscle strength

    Time frame: through study completion, an average of 20 weeks

    Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.

  2. Functional testing : SEBT

    Time frame: 4-6 weeks after ACL injury and through study completion, an average of 20 weeks

  3. Title Questionnaires : Lyshom

    Time frame: 4-6 weeks after ACL injury and through study completion, an average of 20 weeks

  4. Title Questionnaires : confidence questionnaire

    Time frame: 4-6 weeks after ACL injury and through study completion, an average of 20 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ISO-LCA-PREOP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.