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

• Participant Demographics [ Time Frame: baseline ] [ Designated as safety issue: No ]
  Participant age, income, education level, race/ethnicity will be collected to explore possible associations between outcomes and demographic factors.
• Comorbidity [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  Participant comorbidities will be collected to explore possible associations btwn comorbidities and outcomes
• Change in Rapid Assessment of Physical Activity score [ Time Frame: baseline, 24months ] [ Designated as safety issue: No ]
• Change in SF-36 score [ Time Frame: baseline, 2weeks, 6weeks, 3months, 6months, 12months, 24months ] [ Designated as safety issue: No ]
• Bone Mineral Density Testing [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  participant bone mineral density will be collected to control for the possible confounding effect of low bone mineral density
• complications [ Time Frame: 24months ] [ Designated as safety issue: Yes ]
  frequency and type of complications will be assess to determine if particular participant or procedure factors are associated with increased complication frequency
• Therapy compliance [ Time Frame: 6weeks ] [ Designated as safety issue: No ]
  Therapy compliance will be assessed to control for the possible confounding factor of low therapy compliance.
• Change in Hand function [ Time Frame: 6weeks, 3months, 6months, 12months, 24months ] [ Designated as safety issue: No ]

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 21-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.

• Procedure: Open Reduction and Internal Fixation
  Internal fixation with a volar locking plating system
• Procedure: External Fixation
  External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
• Procedure: Percutaneous Pinning
  Pinning with any number of Kirschner wires
• Procedure: Closed Reduction and casting
  closed reduction and immobilization with a cast and/or splint

• Experimental: Internal Fixation
  Intervention: Procedure: Open Reduction and Internal Fixation
• Experimental: External Fixation
  Intervention: Procedure: External Fixation
• Experimental: Pinning
  Intervention: Procedure: Percutaneous Pinning
• Active Comparator: No Surgery
  Intervention: Procedure: Closed Reduction and casting

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 whose delay to emergency department or urgent care presentation was greater than 2 weeks
• 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)

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• National Institute on Aging (NIA)