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Recruiting NCT06590701

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

No phase Interventional Scapholunate Ligament Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early dart throwing motion-mobilization.
Who it may be relevant to
Registry conditions: Scapholunate Ligament Rupture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other Early dart throwing motion-mobilization
    We compare two different mobilisations in the rehabilitation of patients following scapholunate ligament reconstruction

Primary outcome measures

  • Pain in resting position [Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Pain during activity [Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Strength Assessment: Grip Strength [Time frame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
Secondary outcome measures (3)
  • Recording ability to work [Time frame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Recording of physical limitations [Time frame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]
  • Recording wrist pain and restrictions [Time frame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Balgrist University Hospital — Zurich

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. PMID 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. PMID 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. PMID 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. PMID 17996783

Identifiers

NCT: NCT06590701 · SL-Reko

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗