Clinical trial NCT06590701: Scapholunate Ligament Reconstruction: Early Dart Throwing Motion Versus Motion in Anatomical Planes
Official title: Scapholunate Ligament Reconstruction: Early Dart Throwing Motion Versus Motion in Anatomical Planes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scapholunate Ligament Rupture
Keywords: Mobilisation
Scapholunate ligament recontruction
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Pain in resting position
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Pain during activity
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Mobility of the wrist: Flexion
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Mobility of the wrist: Extension
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Mobility of the wrist: Ulnar deviation
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Mobility of the wrist: Pronation
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Mobility of the wrist: Supination
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Strength Assessment: Grip Strength
timeFrame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
Secondary outcomes:
measure: Recording ability to work
timeFrame: Before surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Recording of physical limitations
timeFrame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
measure: Recording wrist pain and restrictions
timeFrame: Before surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Lisa Reissner, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.