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NCT Number: NCT04348253

Danish Multicenter Scapholunate Ligament Study

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

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Key information

Conditions

Ligament Injury Wrist Sprain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Berger

Procedure

Treatment 1

3LT

Procedure

Treatment 2

Primary outcomes

  1. The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)

    Time frame: At all follow-ups (0-10 years)

    points

Secondary outcomes

  1. Grip-strength

    Time frame: At all follow-ups (0-10 years)

    kg

  2. SL angle

    Time frame: At all follow-ups (0-10 years)

    degrees

  3. The Patient-Rated Wrist Evaluation (PRWE) score

    Time frame: At all follow-ups (0-10 years)

    points

  4. Wrist motion

    Time frame: At all follow-ups (0-10 years)

    degrees

Study contacts

Contact information is provided by the study sponsor or research team.

Janni K Thillemann, Dr

CONTACT

[email protected]

+45 28137303

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)

Important dates

Study start
2018
Primary completion
2023
Study completion
2033
First posted
Apr 16, 2020
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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