Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures

Distal Radius Fracture Clinical Trial

— E-MOB  

Official title:

Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576224
• Other study ID #: SJ-275
• Status: Completed
• Phase: N/A
• First received: April 9, 2012
• Last updated: January 23, 2017
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2017
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast.

The primary hypothesis is, that immediate training leads to earlier and faster recovery.

Our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.

Description:

Patients were followed for one year with controls after one, three, six and twelve months. Occupational therapists blinded for the intervention examined the patients at all times. ROM, strength and DASH score was performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Over 50 years of age

• Distal radius fracture suitable for volar locking plate osteosynthesis

• Inhabitants in Region Sjaelland

Exclusion Criteria:

• Dementia

• Abuse of drugs, medication or alcohol

• Open fractures

• Multitrauma or other injures on same extremity

• Earlier wrist fracture

• Delay of osteosynthesis of more than 14 days

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Device:
• Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark
To be removed during training exercises three to five times a day

Locations

Country	Name	City	State
Denmark	Køge Sygehus	Køge

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	Region Sjællands sundhedsvidenskabelige Forskningsfond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability of arm, shoulder and hand score (DASH)		After 4 weeks
Primary	Disability of arm, shoulder and hand score (DASH)		After 3 months
Primary	Disability of arm, shoulder and hand score (DASH)		After 6 months
Primary	Disability of arm, shoulder and hand score (DASH)		After 12 months
Secondary	Range of motion		After 4 weeks
Secondary	Range of motion		After 3 months
Secondary	Range of motion		After 6 months
Secondary	Range of motion		After 12 months
Secondary	Grip strength		After 4 weeks
Secondary	Grip strength		After 3 months
Secondary	Grip strength		After 6 months
Secondary	Grip strength		After 12 months