The Treatment of Clavicular Fractures

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00642265
• Collaborator: AZ Sint-Jan AV (Other)
• Enrollment: 100
• Locations: 6
• Arms: 2
• Duration (Months): 87
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.

Condition or Disease	Intervention/Treatment	Phase
Displaced, Midshaft Clavicular Fractures	Procedure: osteosynthesis; Other: sling	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
• Study Start Date: Apr 1, 2008
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 operative treatment	Procedure: osteosynthesis; operative treatment
Active Comparator: 2 conservative treatment	Other: sling; conservative treatment

Outcome Measures

Primary Outcome Measures

1. Union [1 year]

2. Functionality [1 year]

Secondary Outcome Measures

1. Complications [1 year]

2. Time to heal [1 year]

3. Cost [1 year]

4. Relation with medication [1 year]

5. Relation with smoking [1 year]

6. Relation with job [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 to 65 year

• 100% displaced midshaft clavicular fracture

• shortening

• male: 18mm

• female: 14mm

Exclusion Criteria:

• pregnancy

• pathological fracture

• open fracture

• history of frozen shoulder

• ipsilateral fracture of shoulder or scapula

• neurovascular injury

• contraindication to anaesthesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stedelijk Ziekenhuis Aalst	Aalst		Belgium	9300
2	AZ Sint Jan-Brugge	Brugge		Belgium	8000
3	Jan Palfijnziekenhuis	Ghent		Belgium	9000
4	University Hospital Ghent	Ghent		Belgium	9000
5	Stedelijk Ziekenhuis Roeselare	Roeselare		Belgium	8800
6	Sint-Andries Ziekenhuis	Tielt		Belgium	8700

Sponsors and Collaborators

• University Hospital, Ghent
• AZ Sint-Jan AV

Investigators

• Principal Investigator: Lieven De Wilde, MD, PhD, University Hospital, Ghent
• Principal Investigator: Bart Berghs, MD, AZ Sint-Jan AV
• Principal Investigator: Pieter-Jan Vandekerckhove, MD, Sint-Andriesziekenhuis Tielt
• Principal Investigator: J. Van Den Daele, MD, Stedelijk Ziekenhuis Roeselare
• Principal Investigator: J. Vanonverschelde, MD, Stedelijk Ziekenhuis Aalst
• Principal Investigator: G. Vandendriessche, MD, Jan Palfijnziekenhuis Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00642265
• Other Study ID Numbers: 2007/573
• First Posted: Mar 25, 2008
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Fractures, Bone

Study Results

No Results Posted as of Dec 5, 2014