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

Overview

About this study

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 18-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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator David Dennison, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

David Dennison, M.D.

Closed for enrollment

More information

Publications

The Wrist and Radius Injury Surgery Trial (WRIST) study group is a collaboration of 21 hand surgery centers in the United States, Canada, and Singapore, to showcase the interest and capability of hand surgeons to conduct a multicenter clinical trial. The WRIST study group was formed in response to the seminal systematic review by Margaliot et al and the Cochrane report that indicated marked deficiency in the quality of evidence in the distal radius fracture literature. Since the initial description of this fracture by Colles in 1814, over 2,000 studies have been published on this subject; yet, high-level studies based on the principles of evidence-based medicine are lacking. As we continue to embrace evidence-based medicine to raise the quality of research, the lessons learned during the organization and conduct of WRIST can serve as a template for others contemplating similar efforts. This article traces the course of WRIST by sharing the triumphs and, more important, the struggles faced in the first year of this study. Read More on PubMed
Multicenter clinical trials are important research tools. Planning a multicenter clinical trial is a long and arduous task that requires substantial preparation time. In this guide, the authors discuss the steps used to plan a multicenter clinical trial. A preplanning phase, which involves formulating and refining a research question and conducting pilot studies, is detailed, and the planning phase, which involves the acquisition of funding to support the coordination and preparation of a multicenter clinical trial, culminating in the submission of an R01 grant, is described. An essential asset to planning a multicenter clinical trial is the fluidity with which all collaborators work together toward a common vision. The philosophy among collaborators should be consensus and commitment and is emphasized by the development of a consensus assisted study protocol. Most important are the recruitment of centers and co-investigators who are dedicated, collaborative, and selfless in the team effort to achieve goals that cannot be reached by a single-center effort. Read More on PubMed

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