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Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures

NCT01123447 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-15

No results posted yet for this study

Summary

The purpose of this study is to determine if surgery using a plate and screws to fix a forearm fracture (ulnar shaft) will improve functional outcome compared to non-operative treatment out to 1 year of follow-up. It is hypothesized that in skeletally mature patients with isolated ulnar shaft fractures, the patients treated with surgery will have improved functional outcomes compared to non-surgical treatment with below-elbow cast at 1-year follow-up. This will be measured by the Disabilities of the Arm, Shoulder and Hand (DASH) scores. Secondary outcomes will include SF-36, range of motion, pain, grip strength, return to work, and time to union.

Conditions

  • Fracture
  • Trauma
  • Ulna Fracture
  • Orthopedic
  • Surgery

Interventions

PROCEDURE

Open reduction and internal fixation

Patients will undergo surgery for open reduction of the fracture and internal fixation with an LC-DC plate and screw fixation.

PROCEDURE

Closed reduction and short-arm cast

Patient will undergo a closed reduction and be placed in a short-arm (below-elbow) cast for 6 weeks.

Sponsors & Collaborators

  • Canadian Orthopaedic Research Legacy

    collaborator UNKNOWN

  • Canadian Orthopaedic Trauma Society

    collaborator OTHER

  • Calgary Surgical Research Development Fund

    collaborator OTHER

  • AO Research Fund

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Paul J Duffy, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-02
Primary Completion
2023-03-08
Completion
2023-07-31

Countries

  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123447 on ClinicalTrials.gov