Intramedullary Nailing of Diaphyseal Humeral Fractures - T2™ Humeral Nail versus Fixion ® Intramedullary Humeral Nail

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20978

Enrollment

120

Registered

2007-04-08

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intramedullary - Nailing - Diaphyseal - Humeral Fractures - Fixion Nail - T2 Nail - Intramedullair - humerusschacht - fractuur

Interventions

The patient with the suspicion of a humeral shaft fracture will be examined at the first aid department and will be diagnosed with x-ray. In case of open fractures the wound will be brief inspected, a

Eligibility

Inclusion criteria

Inclusion criteria: Human volunteers with a minimal age of 18 years old with a humeral shaft fracture.

Exclusion criteria

Exclusion criteria: 1. Gustilo and Anderson classification III-C; 2. Primary bone disease: a. Fibrous Dysplasia; b. Gaucher's Disease; c. Osteogenesis Imperfecta; d. Osteomalacia; e. Osteomyelitis; f. Pagets Disease; g. Renal Osteodystrophy; 3. Postoperative treatment in an hospital not participating in the study.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to investigate the peroperative fluoroscopic time.	—

Secondary

Measure	Time frame
Secondary objectives will be: 1. procedure time; 2. number of infections; 3. number of complications; 4. hospitalisation time; 5. resumption of full activities.	—

Contacts

Public ContactM.W. Gosler

Atrium MC/ Afdeling Chirurgie Postbus 4446

FixionNailStudy@gmail.com+31 45-5766599

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)