Prolonged Preoperative Rehabilitation in ACL Rupture.

NCT04888052 | Completed

• 2 other identifiers: 2020_712021-A00598-33
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Rehabilitation; preoperative; strength; isokinetic; anterior cruciate ligament

Outcome Measures

Primary Outcomes (1)

• Muscle strength

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

  4-6 weeks after ACL injury

Secondary Outcomes (4)

• Muscle strength

  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

Study Arms (1)

Group 1

EXPERIMENTAL

Device: Acute ACL injury

Interventions

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).

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Swynghedauw

Lille, 59037, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• André Thevenon, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 17, 2021
• Study Start: October 19, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)