A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures (WRIST)

University of Michigan

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Procedure: Open Reduction and Internal Fixation; Procedure: Percutaneous Pinning; Procedure: External Fixation; Procedure: Closed Reduction and casting

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01589692

R01AR062066-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In the United States, over 300,000 individuals over age 65 suffer from distal radius fractures (DRFs) each year. Despite the frequency of this injury and over 200 years of experience treating DRFs, management of elderly DRFs is still controversial. Close reduction and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures, common in the elderly, often collapse and displace. The three currently applied surgical techniques are close reduction and percutaneous pinning, external fixation with or without percutaneous pinning, and internal fixation with volar locking plating. Preliminary evidence indicates that locking plate fixation can permit elderly patients to move their hands and wrists much sooner in order to return to self-care activities more quickly. Although these outcomes are promising, there is no randomized controlled clinical trial to demonstrate that the more invasive, and perhaps more costly, plating technique is superior to the other simpler approaches.

The specific aim of this 24-center randomized controlled trial is to compare outcomes of these three surgical techniques in treating unstable DRFs in the elderly. The secondary aim is to follow a cohort of elderly patients who choose not to have surgery to evaluate outcomes following treatment by close reduction and casting alone. This clinical trial is the most ambitious study in hand surgery by assembling most of the leading centers in North America to collect evidence-based data to guide future treatment of this prevalent injury in the growing elderly population.

Enrollment: 304 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have an unstable DRF for which surgical fixation is indicated

  o AO type A2, A3, C1, C2

• At least one of the following radiographic criteria indicating fracture instability

  • Dorsal angulation of greater than 10°
  • Radial inclination angle of less than 15°
  • Radial shortening of greater than 3mm

• Patients with the ability to read and understand English (to complete study questionnaires)

• Community-dwelling patients

• Patients 60 years of age or older

Exclusion criteria

• Patients who have suffered open DRFs
• Patients with bilateral DRFs
• Patients with associated upper extremity fractures or ligament injuries (including ulnar styloid fracture, TFCC and wrist ligament injuries) requiring repair at the time of DRF fixation
• Multi-trauma patients
• Patients with prior DRF on the same wrist
• Patients with comorbid conditions prohibiting surgery
• Patients with neurologic disorders that affect hand, wrist or arm sensation or movement
• Patients who have a history of dementia, Alzheimer's Disease or other serious psychiatric disorders
• Patients with current substance abuse
• Patients who do not agree to be randomized
• Patients who have DRFs that are not equally suited for each procedure (i.e. severely comminuted fractures)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 4 patient groups

Internal Fixation

Experimental group

Description:

Open Reduction and Internal Fixation: Internal fixation with a volar locking plating system

Treatment:

Procedure: Open Reduction and Internal Fixation

External Fixation

Experimental group

Description:

External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.

Treatment:

Procedure: External Fixation

Pinning

Experimental group

Description:

Percutaneous pinning with any number of Kirschner wires

Treatment:

Procedure: Percutaneous Pinning

No Surgery

Active Comparator group

Description:

Closed Reduction and casting: Closed reduction and immobilization with a cast and/or splint

Treatment:

Procedure: Closed Reduction and casting