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

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT02154620

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	Procedure: Volar plate Device: Synthes TCP volar plate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Plaster cast The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist
Experimental: Volar plate The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.	Procedure: Volar plate An anatomically countoured volar plate is implanted through a Henry's incision. Other Names: Synthes TCP volar plate for distal radius Device: Synthes TCP volar plate

Arm

Intervention/Treatment

No Intervention: Plaster cast

The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist

Experimental: Volar plate

The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.

Procedure: Volar plate

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

Other Names:

Synthes TCP volar plate for distal radius

Device: Synthes TCP volar plate

Outcome Measures

Primary Outcome Measures

Patient related wrist evaluation (PRWE) [52 weeks]

Secondary Outcome Measures

Patient related wrist evaluation (PRWE) [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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