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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21223

Enrollment

120

Registered

2010-08-01

Start date

2011-01-01

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

dislocated midshaft clavicular fractures gedisloceerde mid-schacht clavicula fracturen

Interventions

Plate fixation or intramedullary fixation with a Titanium Elastic Nail (TEN).

Eligibility

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 <12 (moderate to severe head injury); 8. An inability to comply with follow-up (a transient or an inability to read or complete forms); 9. Pre-existing shoulder pathology in affected side (such as rotator cuff lesion, acromioclavicular pathology or previous shoulder surgery).

Design outcomes

Primary

Measure	Time frame
DASH score 6 months after surgery.	—

Secondary

Measure	Time frame
1. Function of the shoulder (Constant Score) 6 months after surgery; 2. DASH and Constant scores at 6 weeks and 3 months; 3. Complications, both intra-operatively, immediately postoperatively (two weeks), and after 6 months; 3. The number of re-operations related to unsatisfactory results in a period of 6 months; 4. Time to radiological consolidation; 5. Perception of pain 2 weeks postoperatively; 6. Patient satisfaction with the cosmetic result of the treatment 6 months postoperatively.	—

Measure

Time frame

1. Function of the shoulder (Constant Score) 6 months after surgery; 2. DASH and Constant scores at 6 weeks and 3 months; 3. Complications, both intra-operatively, immediately postoperatively (two weeks), and after 6 months; 3. The number of re-operations related to unsatisfactory results in a period of 6 months; 4. Time to radiological consolidation; 5. Perception of pain 2 weeks postoperatively; 6. Patient satisfaction with the cosmetic result of the treatment 6 months postoperatively.

—

Contacts

Public ContactE.J.M.M. Verleisdonk

University Medical Center Utrecht (UMCU), P.O. Box 85500

E.J.M.M.Verleisdonk@umcutrecht.nl+31 (0)30 2506968

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)