Prolonged Preoperative Rehabilitation in ACL Rupture. (ISO-LCA-PREOP)
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acute ACL injury
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Rehabilitation, preoperative, strength, isokinetic, anterior cruciate ligament
Eligibility Criteria
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
Sites / Locations
- Hop SwynghedauwRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1
Arm Description
Outcomes
Primary Outcome Measures
Muscle strength
Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.
Secondary Outcome Measures
Muscle strength
Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.
Functional testing : SEBT
Title Questionnaires : Lyshom
Title Questionnaires : confidence questionnaire
Full Information
NCT ID
NCT04888052
First Posted
April 14, 2021
Last Updated
March 28, 2022
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT04888052
Brief Title
Prolonged Preoperative Rehabilitation in ACL Rupture.
Acronym
ISO-LCA-PREOP
Official Title
Strength Muscular Assessment and Prolonged Preoperative Rehabilitation Interest in the Anterior Cruciate Ligament Rupture - a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Rehabilitation, preoperative, strength, isokinetic, anterior cruciate ligament
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Acute ACL injury
Intervention Description
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 Outcome Measure Information:
Title
Muscle strength
Description
Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.
Time Frame
4-6 weeks after ACL injury
Secondary Outcome Measure Information:
Title
Muscle strength
Description
Muscle strength: measurement of knee extensors and flexors peak torque on isokinetic dynamometer.
Time Frame
through study completion, an average of 20 weeks
Title
Functional testing : SEBT
Time Frame
4-6 weeks after ACL injury and through study completion, an average of 20 weeks
Title
Title Questionnaires : Lyshom
Time Frame
4-6 weeks after ACL injury and through study completion, an average of 20 weeks
Title
Title Questionnaires : confidence questionnaire
Time Frame
4-6 weeks after ACL injury and through study completion, an average of 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
André Thevenon, MD,PhD
Phone
0320445962
Ext
+33
Email
andre.thevenon@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Thevenon, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Swynghedauw
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
12. IPD Sharing Statement
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Prolonged Preoperative Rehabilitation in ACL Rupture.
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