NCT02890862

Brief Summary

Development of reliable and objective evaluation methods is required for natural upper-extremity tasks. Three-dimensional imaging measurement techniques are a powerful tool for quantitative assessment of multijoint movements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

August 18, 2016

Last Update Submit

October 29, 2018

Conditions

Keywords

KinematicsActivity of Daily living3D motion analysis

Outcome Measures

Primary Outcomes (2)

  • Joint angle of finger and wrist (Vicon)

    Position of the Skin markers be measured with the Vicon cameras and the Joint angles will be calculated with matlab program. Maximum range of motion will be compared between first and second measurement.

    36 months

  • Joint angle of finger and wrist (Goniometer)

    Maximum range of motion will be compared between first and second measurement

    36 months

Secondary Outcomes (2)

  • Objective functional parameters: - daily activities: open a bottle, open a glass, type 3 words, write 3 words, turn a key, pick up small object, move heavy object (1/3kg), dart-throwing motion

    36 months

  • Subjective functional parameters: - Mayo Wrist Score - Krimmer Wrist Score - Short Version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)

    36 months

Study Arms (4)

20 healthy volunteers

Dupuytren disease

10 patients dupuytren disease

Tendon pathology

10 patients with tendon pathology

wrist osteoarthritis

10 patients with wrist osteoarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of healty persons, patients with tendon pathologies, arthrosis and dupuytren disease. In the future the new findings should assist the decision of surgical procedures.

You may qualify if:

  • Volunteers of 20 healthy, right dominant hands
  • patients with tendon pathologies
  • patients with Dupuytren disease
  • patients with osteoarthritis of the wrist
  • Patients older than 18 years
  • Patient willing and able to give written informed consent to participate in the study

You may not qualify if:

  • Inflammatory disease (e.g. rheumatoid arthritis)
  • Pregnant women
  • German language barrier to complete the questionnaires
  • Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
  • Legal incompetence
  • Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Center for Reconstructive Surgery

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Maurizio Calcagni, PD Dr. med.

    Plastic surgery and Handsurgery USZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

September 7, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations