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

NCT ID: NCT02154620

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-01-31

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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plaster cast

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Volar plate

Intervention Type: PROCEDURE

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

Synthes TCP volar plate

Intervention Type: DEVICE

Interventions

Volar plate

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

Intervention Type: PROCEDURE

Synthes TCP volar plate

Intervention Type: DEVICE

Other Intervention Names

Synthes TCP volar plate for distal radius

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Sari Ponzer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Enocson, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Department of Orthopaedics, Stockholm South Hospital

Stockholm, , Sweden

Countries

Sweden

References

Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.

Reference Type: DERIVED

PMID: 35549696 (View on PubMed)

Other Identifiers

70

Identifier Type: -

Identifier Source: org_study_id