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Completed

NCT Number: NCT02154620

Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.

An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.

A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics, Stockholm South Hospital

Stockholm, 11883, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
  • Low energy injury
  • Patient 70 years old or older
  • 72 hours or less since injury at time of diagnosis
  • Patient registered in the Stockholm region
  • Patient understands spoken and written swedish

Exclusion criteria

  • Intraarticular displacement in radiocarpal joint of more than 1 mm
  • Ulna fractured proximal to the base of the styloid process of ulna
  • Earlier unilateral functional impairment of hand/wrist
  • Injury to tendon, nerve or skin besides the fracture
  • Rheumatoid arthritis or other severe systemic joint disease
  • Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
  • Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
  • Medical illness that makes general anesthesia impossible

Treatment and study plan

Volar plate

Procedure

An anatomically countoured volar plate is implanted through a Henry's incision.

Other names: Synthes TCP volar plate for distal radius

Synthes TCP volar plate

Device

Primary outcomes

  1. Patient related wrist evaluation (PRWE)

    Time frame: 52 weeks

Secondary outcomes

  1. Patient related wrist evaluation (PRWE)

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial

Acronym: 70

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 3, 2014
Registry last updated
Mar 15, 2021

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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