Danish Multicenter Scapholunate Ligament Study | NCT04348253

Studies
Danish Multicenter Scapholunate Ligament Study

NCT04348253

Sponsor

University of Aarhus

Status

Recruiting

Last Update Posted

Apr 16, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Ligament Injury
Wrist Sprain

Interventions

Berger
3LT

Countries

Denmark

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Apr 30, 2033Estimated

First Submitted Date

Mar 30, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 16, 2020Actual

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 15, 2020

Last Update Posted Date

Apr 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.

Detailed Description

This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Berger	Active Comparator	Bergers capsulodesis	Procedure: Berger
3LT	Active Comparator	Three ligament tenodesis	Procedure: 3LT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Berger	Procedure	Treatment 1	Berger
3LT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)	points	At all follow-ups (0-10 years)

Secondary Outcomes

Measure	Description	Time Frame
Grip-strength	kg	At all follow-ups (0-10 years)
SL angle	degrees	At all follow-ups (0-10 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-60 years (both included).
Symptomatic SL instability (VAS score ³3, QDASH score ³ 20).
> 6 weeks since symptomatic hand trauma (chronic SL lesions).
SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views.
Complete SL ligament lesion confirmed by wrist arthroscopy

Exclusion Criteria:

Geissler grade 1-3 SLL injury (evaluated by arthroscopy).
Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy).
Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy).
Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis.
Adverse effects after extra articular radial fractures (dorsal angulation ³10 grader).
Peroperatively non-reducible scaphoid flexion/SL gap.
Terminal illness or severe medical illness: ASA score higher than or equal to 3.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Janni K Thillemann, Dr	Contact	+45 28137303		teamjanni@gmail.com

Overall Officials

Name	Affiliation	Role
Janni K Thillemann, Dr	Hospitalsenheden Vest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital	Recruiting	Aarhus		8200	Denmark

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