Interference Screw Mectascrew-C Postmarket Study | NCT05791656

Studies
Interference Screw Mectascrew-C Postmarket Study

NCT05791656

Sponsor

Medacta International SA

Status

Unknown status

Last Update Posted

May 1, 2024Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Anterior Cruciate Ligament Injuries
Posterior Cruciate Ligament Tear

Interventions

Mectascrew-C

Countries

Switzerland

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

Apr 2024

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

Mar 22, 2023Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Mar 17, 2023

First Posted Date

Mar 30, 2023Actual

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 30, 2024

Last Update Posted Date

May 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.

Detailed Description

This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.

Patients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).

The data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.

The treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mectascrew-C	Device	reconstruction of ACL or PCL rupture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interference screw presence	via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed	6 months

Secondary Outcomes

Measure	Description	Time Frame
Mobility outcomes evaluation	Assessment throught Range Of Motion of operated knee calculated as degree	1, 3 and 6 months
Functional outcomes evaluation	Assessment throught IKCD score. a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes aged 16-60 yrs
Pre-operative MRI confirming the ACL or PCL rupture
Scheduled for surgical reconstruction of ACL or PCL
BMI>18 and <35 kg/m2
Ability to give informed consent by signature

Exclusion Criteria:

Age under 16 or over 60 yrs
Degenerative osteopathies
Local bone tumors
Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician
Systemic diseases and metabolic disorders that may compromise the outcome of the surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/exclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elisa Bonacina, PhD	Contact	+41 91 696 60 60		bonacina@medacta.ch

Overall Officials

Name	Affiliation	Role
Christian Candrian, Prof Med	EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EOC, Service of Orthopaedics and Traumatology	Recruiting	Lugano		CH-6962	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

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

Browse Leaves

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Browse Branches

Not provided