Clinical trial NCT03014128: Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Official title: Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases or Conditions
Keywords: musculoskeletal disorders
upper extremity
work
surgical instruments
Lead sponsor: District Hospital, Tuttlingen
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Employees of the Aesculap AG, world leader in production of surgical devices

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.


Eligibility criteria: Inclusion Criteria:

* 18-65 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)
timeFrame: 6 months
Secondary outcomes:
measure: Range of wrist motion
timeFrame: 6 months
measure: Grip force of the hand
timeFrame: 6 months
measure: Finger sensibility
timeFrame: 6 months
measure: Stenosing tenosynovitis
timeFrame: 6 months
measure: De Quervain tenosynovitis
timeFrame: 6 months
measure: Nerve entrapment syndromes
timeFrame: 6 months
measure: Carpal tunnel syndrome
timeFrame: 6 months
measure: Tennis elbow (lateral epicondylitis)
timeFrame: 6 months
measure: Purdue Pegboard Test
timeFrame: 6 months
Other outcomes:
Locations:
city: Tuttlingen
country: Germany
facility: Aesculap AG
state: BW
Study officials:
affiliation: Klinikum Landkreis TUT, Zeppelinstraße 21, 78532Tuttlingen/Germany
name: Oliver Lotter, MD
role: PRINCIPAL_INVESTIGATOR
References: