WEakness and Atrophy: isoKinetic With Surface Electromyog... | NCT03200678

Studies
WEakness and Atrophy: isoKinetic With Surface Electromyography Assessment in ACL Surgery

NCT03200678

Sponsor

Direction Centrale du Service de Santé des Armées

Status

Unknown status

Last Update Posted

Apr 14, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Injury
Muscle Weakness

Interventions

isokinetic assessment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017RC01	Other Identifier	DCSSA

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2018Actual

Primary Completion Date

Sep 2023Estimated

Completion Date

Sep 2023Estimated

First Submitted Date

May 23, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2022

Last Update Posted Date

Apr 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.

The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.

Detailed Description

The aim of this study is to assess the qualitative and quantitative variations of the strength, work and fatigue of the thigh muscles after ACL surgery. The reference is the preoperative assessment (V1), the variation is measured on V2 (measurements at 3 months) and V3 (measures at 9 months). Each patient is his own control. In addition, a control group of healthy subjects is used to determine level of significance of each parameter.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACLR Group	Experimental	experimental: ACL surgery Intervention: isokinetic assessment	Other: isokinetic assessment
Control group	Other	other Intervention: isokinetic assessment	Other: isokinetic assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
isokinetic assessment	Other	muscle torque assessement	ACLR Group Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle torque	Newton.meter (N.m)	Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2), measures at 9 months (V3)

Secondary Outcomes

Measure	Description	Time Frame
muscle work	Joule (J)	Change is being assessed between preoperative assessment (V1), measurement at 3 months (V2) and measures at 9 months (V3)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

ACLR group :

men or woman
18 to 45 years old
No injuries sequels on contralateral limb
No contraindication to magnetic resonance imaging

Control group :

men or woman
18 to 45 years old
No limb injuries sequels
No contraindication to magnetic resonance imaging

Exclusion criteria:

age less than 18 years
limb injuries sequels
contraindication to magnetic resonance imaging

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique Tardy	Direction Centrale du Service de Santé des Armées	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital d'Instruction des Armées Clermont-Tonnerre		Brest		29240 Brest Cedex 9	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39981758	Derived	Grimandi R, Tissier F, Garetier M, Labban J, Gerard R, Courtois-Communier E, Andro C, Bisseriex H, Gunepin FX, Rannou F, Giroux-Metges MA. Validity of the Uninjured Limb as a Control for Preoperative Assessment in Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2025 May;43(5):962-972. doi: 10.1002/jor.26057. Epub 2025 Feb 21.

ID	Term
D000070598	Anterior Cruciate Ligament Injuries
D018908	Muscle Weakness
D005221	Fatigue

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries
D009135	Muscular Diseases