Surgical treatment of midshaft clavicular fractures with dislocation: plate fixation versus intramedullary fixation

Surgical treatment of midshaft clavicular fractures with dislocation: plate fixation versus intramedullary fixation - The Plate Or Pin study: *POP* study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39026

Enrollment

120

Registered

2010-10-19

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

broken collarbone clavicular fracture

Interventions

plate fixation or intramedullary fixation with a Titanium Elastic Nail (TEN)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Unilateral dislocated midshaft clavicular fracture 2) No medical contraindications to general anesthesia 3) Provided informed consent

Exclusion criteria

Exclusion criteria: 1) Age 65 years 2) Multitrauma patients 3) Open fracture 4) Pathological fracture 5) Fracture > 1 month old 6) Neurovascular disorders 7) Glasgow Coma Scale

Design outcomes

Primary

Measure	Time frame
DASH score 6 months after surgery	—

Secondary

Measure	Time frame
DASH score after one year function of the shoulder (Constant Score) 6 months after surgery DASH and Constant scores at 6 weeks and 3 months complications, both intra-operatively, immediately postoperatively (two weeks), and in a period of 1 year after surgery. the number of re-operations related to unsatisfactory results in a period of one year after surgery time to radiological consolidation perception of pain 2 weeks postoperatively patient satisfaction with the cosmetic result of the treatment 6 months and one year after surgery. elective implant removal in a period of one year after surgery Addendum: scapulothoracic rythm one year postoperatively (pilot study)	—

Measure

Time frame

DASH score after one year function of the shoulder (Constant Score) 6 months after surgery DASH and Constant scores at 6 weeks and 3 months complications, both intra-operatively, immediately postoperatively (two weeks), and in a period of 1 year after surgery. the number of re-operations related to unsatisfactory results in a period of one year after surgery time to radiological consolidation perception of pain 2 weeks postoperatively patient satisfaction with the cosmetic result of the treatment 6 months and one year after surgery. elective implant removal in a period of one year after surgery Addendum: scapulothoracic rythm one year postoperatively (pilot study)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)