Anterior Cruciate Ligament Rupture | NCT02740452

Studies
Anterior Cruciate Ligament Rupture

NCT02740452

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Mar 15, 2022Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Rupture

Interventions

ligamys technique
standard technique (anatomic reconstruction)

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

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Mar 25, 2016

First Submission Date that Met QC Criteria

Apr 12, 2016

First Posted Date

Apr 15, 2016Estimated

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

Mar 14, 2022

Last Update Posted Date

Mar 15, 2022Actual

Name	Class
Société Mathys SA for sponsoring Ligamys Device	UNKNOWN

Description Module

Brief Summary

The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.

The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

Detailed Description

The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.

Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.

It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ligamys technique	Other	Ligamys technique (device) or standard technique	Device: ligamys technique
standard technique	Other	Ligamys technique (device) or standard technique	Other: standard technique (anatomic reconstruction)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ligamys technique	Device	Ligamys technique (device) or standard technique	Ligamys technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring anterior knee laxity with KT 1000 arthrometer		at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Tegnér scores		at 12 months
Lysholm scores		at 12 months
IKDC score safety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 to 35 years
Primary Anterior Cruciate Ligament rupture
signed patient consent
surgery 21 days or less after traumatism for Ligamys technique

Exclusion Criteria:

infection of the operating site
previous osseous disease
pregnant or nursing woman.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Stéphane DESCAMPS	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries
D012421	Rupture

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided