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Scapholunate Ligament RuptureSL-RekoNCT06590701

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

A study testing Early dart throwing motion-mobilization in people with Scapholunate Ligament Rupture, run by Lisa Reissner at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Scapholunate Ligament Rupture
What is being tested?
Early dart throwing motion-mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSwitzerland
Study dates
1 Jul 2023to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age under 18 years
  • Refusal of participation
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Reissner, PD contact

044 386 57 47

lisa.reissner@balgrist.ch

Andreas Schweizer, Prof contact

044 386 11 11

andreas.schweizer@balgrist.ch

Switzerland1 site, 1 recruiting

  • Balgrist University Hospital

    Zurich, Canton of Zurich, 8008

    Lisa Reissner, PD Dr.med., +41 44 386 57 47, lisa.reissner@balgrist.ch

    Stefani Dossi, +41 44 510 73 76, stefani.dossi@balgrist.ch

    Recruiting

Other trials in Switzerland

About this study

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.

Read the detailed description

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.

Being tested
Early dart throwing motion-mobilization
Keywords
Mobilisation, Scapholunate ligament recontruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early dart throwing motion-mobilizationOther

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

Study groups in NCT06590701
Study groupRoleWhat they receive
Early dart throwing motionExperimentalFrom the 2nd postoperative week, the 'Dart-Throwing Motion' is started, from radial extension to ulnar flexion.
Receives: Other: Early dart throwing motion-mobilization
Mobilisation in anatomical planesActive comparatorFrom the 2nd postoperative week, movements are started in the anatomical plane of the hand (standard rehabilitation)
Receives: Other: Early dart throwing motion-mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain in resting position

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  2. Pain during activity

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  3. Mobility of the wrist: Flexion

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  4. Mobility of the wrist: Extension

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  5. Mobility of the wrist: Ulnar deviation

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  6. Mobility of the wrist: Pronation

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  7. Mobility of the wrist: Supination

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  8. Strength Assessment: Grip Strength

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

    Measured: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

Secondary outcomes (3)

  1. Recording ability to work

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

    Measured: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  2. Recording of physical limitations

    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).

    Measured: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

  3. Recording wrist pain and restrictions

    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.

    Measured: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Jul 2023
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06590701
Sponsor's protocol ID
SL-Reko
Acronym
SL-Reko
Status last verified
May 2024
First submitted
29 May 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Crisco JJ, Wilcox BJ, Beckwith JG, Chu JJ, Duhaime AC, Rowson S, Duma SM, Maerlender AC, McAllister TW, Greenwald RM. Head impact exposure in collegiate football players. J Biomech. 2011 Oct 13;44(15):2673-8. doi: 10.1016/j.jbiomech.2011.08.003. Epub 2011 Aug 27.

    PubMed 21872862

  • Werner FW, Green JK, Short WH, Masaoka S. Scaphoid and lunate motion during a wrist dart throw motion. J Hand Surg Am. 2004 May;29(3):418-22. doi: 10.1016/j.jhsa.2004.01.018.

    PubMed 15140483

  • Crisco JJ, Coburn JC, Moore DC, Akelman E, Weiss AC, Wolfe SW. In vivo radiocarpal kinematics and the dart thrower's motion. J Bone Joint Surg Am. 2005 Dec;87(12):2729-2740. doi: 10.2106/JBJS.D.03058.

    PubMed 16322624

  • Moritomo H, Apergis EP, Herzberg G, Werner FW, Wolfe SW, Garcia-Elias M. 2007 IFSSH committee report of wrist biomechanics committee: biomechanics of the so-called dart-throwing motion of the wrist. J Hand Surg Am. 2007 Nov;32(9):1447-53. doi: 10.1016/j.jhsa.2007.08.014.

    PubMed 17996783

Questions about this trial

What is this clinical trial studying?

A study testing Early dart throwing motion-mobilization in people with Scapholunate Ligament Rupture, run by Lisa Reissner at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Reissner, PD (044 386 57 47, lisa.reissner@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain in resting position (time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06590701, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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