Danish Multicenter Scapholunate Ligament Study

NCT ID: NCT04348253

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2033-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ligament Injury Wrist Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Scares are identical. Patient and examiner are blinded

Study Groups

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Berger

Bergers capsulodesis

Group Type ACTIVE_COMPARATOR

Berger

Intervention Type PROCEDURE

Treatment 1

3LT

Three ligament tenodesis

Group Type ACTIVE_COMPARATOR

3LT

Intervention Type PROCEDURE

Treatment 2

Interventions

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Berger

Treatment 1

Intervention Type PROCEDURE

3LT

Treatment 2

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janni K Thillemann, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospitalsenheden Vest

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Hospital Unit Vest

Holstebro, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Janni K Thillemann, Dr

Role: CONTACT

+45 28137303

Facility Contacts

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Maiken Stilling, Professor

Role: primary

Janni K Thillemann, Dr

Role: primary

+4528137303

Other Identifiers

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1-10-72-169-18

Identifier Type: -

Identifier Source: org_study_id

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