Safety and Performance of the TFCC FastFix in the Wrist | NCT03756714

Studies
Safety and Performance of the TFCC FastFix in the Wrist

NCT03756714

Sponsor

Smith & Nephew, Inc.

Status

Completed

Last Update Posted

Oct 5, 2021Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair

Interventions

Not provided

Countries

United States

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2018Actual

Primary Completion Date

Sep 29, 2021Actual

Completion Date

Sep 29, 2021Actual

First Submitted Date

Nov 27, 2018

First Submission Date that Met QC Criteria

Nov 27, 2018

First Posted Date

Nov 28, 2018Actual

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

Oct 1, 2021

Last Update Posted Date

Oct 5, 2021Actual

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

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

88Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate (%) of clinical success of six months post-operative. Clinical success is defined as wrists without signs of device failure and/or re-intervention after assessment by surgeon		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have undergone TFCC repair using the TFCC FastFix Device
Patients aged 18 years and older
Patients that are > 12 months post-operative.

Exclusion Criteria:

Subjects who are < 12 months post-operative
Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who had TFCC repair using TFCC FastFix device

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Mangin	Smith & Nephew, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Miami Orthopedics & Sport Medicine Institute		Miami	Florida	33146	United States

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