Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures

NCT02679066 | Terminated Results

• 1 other identifier: IRB00087273
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There is no consensus regarding the need to immobilize the elbow in immediate immobilization of closed distal radius fractures post-reduction. Decreased functionality of the upper extremity is a notable morbidity associated with below-elbow splinting of distal radius fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting versus short-arm casting as methods of immediate post-reduction immobilization. The study will randomize patients with close distal radius fractures to short forearm casting versus sugar tong splinting with close follow up including radiographic and clinical evaluation. This will provide guidance regarding the need for short forearm cast immobilization versus sugar tong splinting in early maintenance of reduction of closed distal radius fractures, as well as functional effects of sugar tong splinting versus short forearm casting.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Maintenance of Reduction

  Radiologic parameters to include radial height, radial inclination and volar tilt will be measured from post-immobilization radiographs at presentation, one week, two weeks and four weeks. Maintenance of reduction will be defined as: loss of reduction of \< 2 mm radial height, \< 5 degrees of radial inclination or \< 10 degrees of volar tilt and/or \< 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-reduction radiographs.

  one month

Secondary Outcomes (1)

• Disabilities of the Arm, Shoulder and Hand (DASH) Score - Upper Extremity Function

  Two weeks

Study Arms (2)

Sugar-tong splint

ACTIVE COMPARATOR

Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture.

Device: Sugar-tong splint

Short Forearm Cast

ACTIVE COMPARATOR

Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture.

Device: Short forearm cast

Interventions

Sugar-tong splint DEVICE

Plaster immobilization including the elbow

Sugar-tong splint

Short forearm cast DEVICE

Fiberglass immobilization with elbow free

Short Forearm Cast

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult \> 18 years of age
• Closed fracture
• Isolated injury
• No prior injury to ipsilateral forearm
• Less than or equal to two attempts at reduction

You may not qualify if:

• Ipsilateral upper extremity injury
• Open injury or neurovascular compromise
• Greater than two attempts at reduction
• Presentation greater than 24 hours after injury

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, United States

Location

Related Publications (5)

• Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975 Apr;57(3):311-7.

  PMID: 1123382 BACKGROUND

• Bong MR, Egol KA, Leibman M, Koval KJ. A comparison of immediate postreduction splinting constructs for controlling initial displacement of fractures of the distal radius: a prospective randomized study of long-arm versus short-arm splinting. J Hand Surg Am. 2006 May-Jun;31(5):766-70. doi: 10.1016/j.jhsa.2006.01.016.

  PMID: 16713840 BACKGROUND

• Grafstein E, Stenstrom R, Christenson J, Innes G, MacCormack R, Jackson C, Stothers K, Goetz T. A prospective randomized controlled trial comparing circumferential casting and splinting in displaced Colles fractures. CJEM. 2010 May;12(3):192-200. doi: 10.1017/s1481803500012239.

  PMID: 20522283 BACKGROUND

• Pool C. Colles's fracture. A prospective study of treatment. J Bone Joint Surg Br. 1973 Aug;55(3):540-4. No abstract available.

  PMID: 4125714 BACKGROUND

• Millett PJ, Rushton N. Early mobilization in the treatment of Colles' fracture: a 3 year prospective study. Injury. 1995 Dec;26(10):671-5. doi: 10.1016/0020-1383(95)00146-8.

  PMID: 8745803 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Results Point of Contact

• Title: Erik Hasenboehler MD
• Organization: Johns Hopkins Bayview

ehasenb1@jhmi.edu

4105504190

Study Officials

• Erik Hasenboehler, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 10, 2016
• Study Start: January 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)