NCT06590701

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jul 2023Dec 2028

Study Start

First participant enrolled

July 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

4.9 years

First QC Date

May 29, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

MobilisationScapholunate ligament recontruction

Outcome Measures

Primary Outcomes (8)

  • 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.

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

  • 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

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

  • Mobility of the wrist: Flexion

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

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

  • Mobility of the wrist: Extension

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

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

  • Mobility of the wrist: Ulnar deviation

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

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

  • Mobility of the wrist: Pronation

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

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

  • Mobility of the wrist: Supination

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

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

  • Strength Assessment: Grip Strength

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

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

Secondary Outcomes (3)

  • Recording ability to work

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

  • Recording of physical limitations

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

  • Recording wrist pain and restrictions

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

Study Arms (2)

Early dart throwing motion

EXPERIMENTAL

From the 2nd postoperative week, the 'Dart-Throwing Motion' is started, from radial extension to ulnar flexion.

Other: Early dart throwing motion-mobilization

Mobilisation in anatomical planes

ACTIVE COMPARATOR

From the 2nd postoperative week, movements are started in the anatomical plane of the hand (standard rehabilitation)

Other: Early dart throwing motion-mobilization

Interventions

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

Early dart throwing motionMobilisation in anatomical planes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Refusal of participation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (4)

  • 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: 21872862BACKGROUND
  • 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: 15140483BACKGROUND
  • 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: 16322624BACKGROUND
  • 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: 17996783BACKGROUND

Study Officials

  • Lisa Reissner, PD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Schweizer, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

May 29, 2024

First Posted

September 19, 2024

Study Start

July 1, 2023

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 19, 2024

Record last verified: 2024-05

Locations