Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures

Surgery Clinical Trial

Official title:

A Prospective Randomized Trial Comparing Open Reduction and Internal Fixation With Non-operative Treatment for Ulnar Shaft Fractures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01123447
• Other study ID #: REB14-2004
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2010
• Est. completion date: July 2023

Study information

• Verified date: August 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ulnar diaphyseal, or "nightstick", fractures are uncommon, but fraught with complications (Pollock et al., 1983; Grace & Witmer, 1980, Atkin et al., 1995) and may prevent return to work (Atkin et al., 1995). 3 systematic reviews have concluded that there is insufficient evidence to guide treatment of isolated ulnar shaft fractures (Handoll & Pearce, 2000; Mackay et al., 2000; Bhandari & Schemitsch, 2004) and there has been no comparison between operative and non-operative management. Therefore, there is true clinical equipoise regarding optimal treatment of these injuries.

The aim of this study is to determine if open reduction and internal fixation (ORIF) is more efficacious than closed reduction and below-elbow casting for 6 weeks in restoring function of the forearm and wrist.

We hypothesize that in skeletally mature patients with isolated ulnar shaft fractures, ORIF will improve functional outcomes compared to non-operative treatment with below-elbow cast at 1-year follow-up.

The primary objective is to compare Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1-year post-injury. Secondary outcome measures include SF-36, range of motion, pain, grip strength, return to work and time to union.

The study design is a multi-centre, open-label parallel randomized clinical trial. 100 skeletally mature patients with closed, extra-articular isolated ulnar diaphyseal fractures will be randomized to one of the two treatment arms. Polytrauma patients or those with pre-existing bone pathology will be excluded. Post-treatment follow-up evaluation will occur at 2, 6 and 12 weeks and at 6 and 12 months. Interim analysis will be completed by an independent Data Safety and Monitoring Committee to ensure patient safety.

Radiologic displacement, angulation and time to union will be evaluated by two independent, blinded observers. Time to fracture union will be defined as bridging callus across the fracture line on 2 views.

The sample size was calculated as 50 patients per group. Independent samples t-test will be used to compare the DASH and SF-36 scores and return to work. An ANOVA will be used for the DASH, SF-36 and range of motion comparison at each follow-up.

There is true clinical equipoise regarding optimal treatment for isolated ulnar diaphyseal fractures, therefore, the results of this trial will provide robust evidence for clinical decision-making in the treatment of these injuries by orthopaedic surgeons.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Pathologic fracture

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Orthopedic
• Surgery
• Trauma
• Ulna Fracture
• Ulna Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Dr. Paul J Duffy	Calgary	Alberta
Canada	Queen Elizabeth II Hospital	Halifax	Nova Scotia
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Memorial University	St. John's	Newfoundland and Labrador
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
United Kingdom	North Bristol NHS Trust	Bristol

Sponsors (5)

Lead Sponsor	Collaborator
University of Calgary	AO Research Fund, Calgary Surgical Research Development Fund, Canadian Orthopaedic Research Legacy, Canadian Orthopaedic Trauma Society

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Range of Motion	An evaluation of the range of motion about the wrist and the elbow for both the affected limb and the unaffected limb post-treatment. It will be evaluated starting at 2 weeks for the surgical group and at 6 weeks for the below-elbow cast group.	2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Secondary	Grip Strength	An evaluation of the grip strength for both the affected limb and the unaffected limb post-treatment.	6 weeks, 12 weeks, 6 months, 12 months
Secondary	Radiologic outcome - time to union (fracture healing)	Radiologic outcome will be evaluated based on bridging callus evident on 2 x-ray views (AP and lateral). Time to union will be defined as bridging callus evide on 2 x-ray views.	baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Secondary	SF-36	36-item, self-reported questionnaire is an outcome tool that examines patient-reported overall health and ease of activities of daily living	baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Secondary	Pain Visual Analogue Score	• A standardized pain visual analogue scale will be used to rate pain with various activities of daily living on a scale from 0-10	baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Secondary	DASH score	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	baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months