Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-31 @ 11:47 PM
Study NCT ID:
NCT03014128
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Sponsor:
District Hospital, Tuttlingen
Organization:
Study Overview
Official Title:
Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEIN
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: