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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06590701
Acronym
SL-Reko
Enrollment
40
Registered
2024-09-19
Start date
2023-07-01
Completion date
2028-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scapholunate Ligament Rupture

Keywords

Mobilisation, Scapholunate ligament recontruction

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.

Interventions

OTHEREarly dart throwing motion-mobilization

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

Sponsors

Lisa Reissner
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Strength Assessment: Grip StrengthBefore surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryUsing the Jamar Hydraulic Hand Dynamometer which displays isometric grip force from 0-90 kg, grip strength will be assessed.
Mobility of the wrist: Ulnar deviationBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of wrist ulnar deviation by measuring the range of motion in degrees.
Mobility of the wrist: PronationBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of wrist pronation by measuring the range of motion in degrees.
Mobility of the wrist: SupinationBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of wrist supination by measuring the range of motion in degrees.
Pain in resting positionBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of resting pain using the VAS Score (Visual Analog Scale), where 0 indicates no pain and 10 indicates the worst pain.
Pain during activityBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of pain during activity using the VAS (Visual Analog Scale), where 0 indicates no pain and 10 indicates the worst pain
Mobility of the wrist: FlexionBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of wrist flexion by measuring the range of motion in degrees.
Mobility of the wrist: ExtensionBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryAssessment of wrist extension by measuring the range of motion in degrees.

Secondary

MeasureTime frameDescription
Recording of physical limitationsBefore surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryUsing 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).
Recording wrist pain and restrictionsBefore surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryUsing 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.
Recording ability to workBefore surgery, 7 weeks after surgery, 11 weeks after surgery, 6 months after surgery, 12 months after surgeryDegree of employment in per cent (from 0 to a maximum of 100 per cent) is recorded

Countries

Switzerland

Contacts

Primary ContactLisa Reissner, PD
lisa.reissner@balgrist.ch044 386 57 47
Backup ContactAndreas Schweizer, Prof
andreas.schweizer@balgrist.ch044 386 11 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026