NCT03014128

Brief Summary

Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to many occupational situations and specific industries. However, there is conflicting information about monotonous and repetitive activities. In this context, the profession of surgical device mechanics has not been analyzed so far. The objective of this study is to examine surgical device mechanics at different workplaces with varying work contents and to compare them with a control group without the repetitive workload exposition as described above. The headquarters and main production site of Aesculap are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical devices. After statistical power analysis, the investigators plan to randomize and include a total of 90 voluntary test persons in 3 groups (30 persons each). The study will include standardized questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test). Primary and secondary endpoints were defined to show if significant difference between surgical device mechanics and a control group is present.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

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

First Submitted

Initial submission to the registry

December 20, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

December 20, 2016

Last Update Submit

May 2, 2019

Conditions

Musculoskeletal Diseases or Conditions

Keywords

musculoskeletal disordersupper extremityworksurgical instruments

Outcome Measures

Primary Outcomes (1)

  • DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)

    Validated questionnaire for upper extremity assessment (link in the reference section)

    6 months

Secondary Outcomes (9)

  • Range of wrist motion

    6 months

  • Grip force of the hand

    6 months

  • Finger sensibility

    6 months

  • Stenosing tenosynovitis

    6 months

  • De Quervain tenosynovitis

    6 months

  • +4 more secondary outcomes

Study Arms (3)

Inspection and Packaging

self-descriptive

Other: Clinical examination and data processing of questionnaires

Grinding, Polishing and Matting

self-descriptive

Other: Clinical examination and data processing of questionnaires

All other employees at Aesculap (not in first 2 groups)

including administration and offices as well as all other mechanical workplaces

Other: Clinical examination and data processing of questionnaires

Interventions

Clinical examination and data processing of questionnairesOTHER

xy

All other employees at Aesculap (not in first 2 groups)Grinding, Polishing and MattingInspection and Packaging

Eligibility Criteria

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

Employees of the Aesculap AG, world leader in production of surgical devices

You may qualify if:

  • years of age
  • work ability without absence \> 2 weeks within the last 3 months
  • \>5 years on workplace or similar workplace when in group of surgical device mechanics

You may not qualify if:

  • spinal syndrome in history
  • chronic shoulder pain in history
  • congenital malformation of the upper extremity/hand
  • rheumatoid arthritis or fibromyalgia in history
  • actual hand therapy as conservative therapy or therapy after operation due to upper extremity musculoskeletal pathology
  • previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal pathology of the upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aesculap AG

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

Related Links

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Oliver Lotter, MD

    Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 9, 2017

Study Start

March 2, 2017

Primary Completion

January 26, 2018

Study Completion

May 31, 2018

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations

DE(1)