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Completed

NCT Number: NCT01576224

Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Køge Sygehus

Køge, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removable splint "omni med", Fischer Medical Aps, DK-2800 Lyngby, Denmark

Device

To be removed during training exercises three to five times a day

Primary outcomes

  1. Disability of arm, shoulder and hand score (DASH)

    Time frame: After 4 weeks

  2. Disability of arm, shoulder and hand score (DASH)

    Time frame: After 3 months

  3. Disability of arm, shoulder and hand score (DASH)

    Time frame: After 6 months

  4. Disability of arm, shoulder and hand score (DASH)

    Time frame: After 12 months

Secondary outcomes

  1. Range of motion

    Time frame: After 4 weeks

  2. Range of motion

    Time frame: After 3 months

  3. Range of motion

    Time frame: After 6 months

  4. Range of motion

    Time frame: After 12 months

  5. Grip strength

    Time frame: After 4 weeks

  6. Grip strength

    Time frame: After 3 months

  7. Grip strength

    Time frame: After 6 months

  8. Grip strength

    Time frame: After 12 months

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Region Sjællands sundhedsvidenskabelige Forskningsfond

Registry information

Official study title

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

Acronym: E-MOB

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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