Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06590701

Scapholunate Ligament Reconstruction: Early Dart Throwing Motion Versus Motion in Anatomical Planes

Patients undergoing scapholunate ligament reconstruction at Balgrist University Hospital are divided into two groups and receive two different types of mobilisation postoperatively. The investigators will compare the outcome (pain, strength, mobility) between the two groups 1 year after the operation.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Scapholunate Ligament Rupture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The so-called 'dart-throwing motion' (DTM) plane of movement, from radial extension to ulnar flexion, has gained attention as it has been shown to be an important axis of wrist movement during activities of daily living. Further studies have shown that during movement of the intact wrist in the dart throwing plane, most of the movement occurs in the mediocarpal joint, while the proximal row remains relatively immobile.

In scapholunate (SL) ligament reconstruction using the flexor carpi radialis tendon, the SL interval is immobilised using 2 Kirschner wires for 8-10 weeks to relieve the strain on the ligament and allow it to heal. From the 2nd postoperative week, mobilisation is started using DTM mobilisation or mobilisation in the anatomical plane. The aim of the study is to investigate in a randomised trial whether mobilisation in the anatomical plane produces the same postoperative results.

In this project, the investigators will compare two types of mobilisation in the rehabilitation of SL ligament reconstruction. The participants will be randomised to two treatment groups. This procedure therefore corresponds to a risk category A in 'other' clinical trials according to Chapter 4 ClinO.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • SL Ligament reconstruction at Balgrist University Hospital
  • at least 18 years
  • Written informed consent

Exclusion criteria

  • Age under 18 years
  • Refusal of participation
  • Pregnancy

Treatment and study plan

Early dart throwing motion-mobilization

Other

We compare two different mobilisations in the rehabilitation of patients following scapholunate ligament reconstruction

Primary outcomes

  1. Pain in resting position

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of resting pain using the VAS Score (Visual Analog Scale), where 0 indicates no pain and 10 indicates the worst pain.

  2. Pain during activity

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of pain during activity using the VAS (Visual Analog Scale), where 0 indicates no pain and 10 indicates the worst pain

  3. Mobility of the wrist: Flexion

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of wrist flexion by measuring the range of motion in degrees.

  4. Mobility of the wrist: Extension

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of wrist extension by measuring the range of motion in degrees.

  5. Mobility of the wrist: Ulnar deviation

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of wrist ulnar deviation by measuring the range of motion in degrees.

  6. Mobility of the wrist: Pronation

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of wrist pronation by measuring the range of motion in degrees.

  7. Mobility of the wrist: Supination

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Assessment of wrist supination by measuring the range of motion in degrees.

  8. Strength Assessment: Grip Strength

    Time frame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Using the Jamar Hydraulic Hand Dynamometer which displays isometric grip force from 0-90 kg, grip strength will be assessed.

Secondary outcomes

  1. Recording ability to work

    Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Degree of employment in per cent (from 0 to a maximum of 100 per cent) is recorded

  2. Recording of physical limitations

    Time frame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Using the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire, physical limitation will be recorded. This 30-item questionnaire allows patients to rate difficulty and interference with daily life on a 5-point Likert scale. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).

  3. Recording wrist pain and restrictions

    Time frame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

    Using the PRWE (Patient-Rated Wrist Evaluation) questionnaire, specific wrist pain and restrictions will be recorded. This 15-item questionnaire measures wrist pain and disability in daily activities. Patients rate their wrist pain and disability from 0 (no pain) to 10 (worst pain).

    • Pain subscale:Contains 5 items, each rated from 0 to 10, with a maximum score of 50 and a minimum of 0.
    • Function subscale: Contains 10 items divided into two sections: specific activities (6 items) and usual activities (4 items). The maximum score is 50 and the minimum is 0.

Study contacts

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

Andreas Schweizer, Prof

CONTACT

[email protected]

044 386 11 11

Lisa Reissner, PD

CONTACT

[email protected]

044 386 57 47

Sponsors and collaborators

Lead sponsor

Lisa Reissner

Other

Registry information

Acronym: SL-Reko

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.