NCT01123447

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2010

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

12.7 years

First QC Date

May 10, 2010

Last Update Submit

August 10, 2022

Conditions

FractureTraumaUlna FractureOrthopedicSurgery

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (The DASH)

    30-item, self-reported questionnaire that evaluates function of the affected upper extremity and will reveal the impact of the forearm injury on the function of the entire limb

    1 year

Secondary Outcomes (6)

  • Range of Motion

    2 weeks, 6 weeks, 12 weeks, 6 months, 12 months

  • Grip Strength

    6 weeks, 12 weeks, 6 months, 12 months

  • Radiologic outcome - time to union (fracture healing)

    baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months

  • SF-36

    baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months

  • Pain Visual Analogue Score

    baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Isolated ulnar shaft fractures will be treated with open reduction and internal fixation using a limited contact dynamic compression (LC-DC) plate with screws. These will remain at the fracture site for the lifetime of the patient.

Procedure: Open reduction and internal fixation

Short arm cast

ACTIVE COMPARATOR

Those individuals randomized to the non-operative treatment group will be treated with a closed reduction and short-arm (below-elbow) cast.

Procedure: Closed reduction and short-arm cast

Interventions

Open reduction and internal fixationPROCEDURE

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

Also known as: Limited contact dynamic compression plate (LC-DC) with screw fixation
Surgery
Closed reduction and short-arm castPROCEDURE

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

Short arm cast

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Over 16 years of age and skeletally mature
  • Subject has an isolated extra-articular ulnar diaphyseal fracture
  • Subject presents within 14 days or less between injury and study recruitment
  • Patient must be medically fit for anesthesia
  • Subject is willing and able to provide written informed consent for trial participation
  • Subject is willing and able to comply with the study protocol including return for all follow-up evaluations
  • Subject has an isolated ulnar diaphyseal fracture (AO type 22A1.1, 22A1.2, 23A1.2, 23A1.3, 22B1.1, 22B1.2) without extension to the articular surface
  • Fracture is displaced, but displacement is \<50% after closed reduction, if closed reduction is required
  • Fracture less than 30-degrees of angulation following closed reduction, if closed reduction is required

You may not qualify if:

  • Subject has a pre-existing ipsilateral wrist injury, degenerative condition, or congenital anomaly
  • Subject has a delay in treatment greater than 14 days from time of injury
  • Subject has an active infection in the area of surgical approach
  • Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong ulnar fracture healing time (another long bone fracture, ipsilateral limb injury)
  • Subject has a history of rheumatoid arthritis, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis
  • Subject has a high risk of death from surgery (ASA physical status Class V)
  • Subject is likely unable to maintain follow-up (no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc)
  • Subject has cognitive impairment or language difficulties that would impeded the valid completion of questionnaires
  • Subject is pregnant
  • Subject is a prisoner, currently detained
  • Subject has an articular fracture (AO Type 23A1.1, 23B or 23C)
  • Open ulnar fracture (any Gustilo grade)
  • Segmental fracture
  • Fractures within 2 cm of the distal radioulnar joint (AO 23A1.1)
  • Fracture of the proximal 1/3 of the ulnar shaft (i.e. Monteggia fracture pattern, AO Type 21A, 22A1.3, 22B1.3)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dr. Paul J Duffy

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Memorial University

St. John's, Newfoundland and Labrador, Canada

Location

Queen Elizabeth II Hospital

Halifax, Nova Scotia, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

MeSH Terms

Conditions

Fractures, BoneWounds and InjuriesUlna Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Forearm InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Paul J Duffy, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Orthopaedic Trauma

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 14, 2010

Study Start

July 2, 2010

Primary Completion

March 8, 2023

Study Completion

July 1, 2023

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

CA(8)GB(1)