FractureNCT01123447
Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures
A study testing Open reduction and internal fixation and Closed reduction and short-arm cast in people with Fracture and Trauma, run by University of Calgary at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fracture, Trauma, Ulna Fracture
- What is being tested?
- Open reduction and internal fixation and Closed reduction and short-arm cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 2 Jul 2010to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Canada8 sites
Dr. Paul J Duffy
Calgary, Alberta, T2N 2T9
Queen Elizabeth II Hospital
Halifax, Nova Scotia
McGill University Health Centre
Montreal, Quebec
Royal Columbian Hospital
New Westminster, British Columbia
Ottawa Hospital
Ottawa, Ontario
Memorial University
St. John's, Newfoundland and Labrador
St. Michael's Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: A Prospective Randomized Trial Comparing Open Reduction and Internal Fixation With Non-operative Treatment for Ulnar Shaft Fractures
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.
Read the detailed 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.
- Conditions
- Fracture, Trauma, Ulna Fracture, Orthopedic, Surgery
- Being tested
- Open reduction and internal fixation, Closed reduction and short-arm cast
- Medical subject headings
- Fractures, Bone, Wounds and Injuries, Ulna Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Also called Limited contact dynamic compression plate (LC-DC) with screw 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 castProcedure or surgery
Patient will undergo a closed reduction and be placed in a short-arm (below-elbow) cast for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Closed reduction and short-arm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
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.
Measured: 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Grip Strength
An evaluation of the grip strength for both the affected limb and the unaffected limb post-treatment.
Measured: 6 weeks, 12 weeks, 6 months, 12 months
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.
Measured: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
SF-36
36-item, self-reported questionnaire is an outcome tool that examines patient-reported overall health and ease of activities of daily living
Measured: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
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
Measured: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
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
Measured: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study start2 Jul 2010
- Primary completion8 Mar 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Orthopaedic Research Legacy, Canadian Orthopaedic Trauma Society, Calgary Surgical Research Development Fund, AO Research Fund
- Responsible party
- Principal investigator, Paul Duffy, University of Calgary
- Investigators
- Paul J Duffy, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123447
- Sponsor's protocol ID
- REB14-2004
- Status last verified
- Aug 2022
- First submitted
- 10 May 2010
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Open Reduction and Internal Fixation With Non-operative Treatment for Ulnar Shaft Fractures
- ClinicalTrials.gov ID
- NCT01123447
- Acronym / sponsor ID
- REB14-2004
- Conditions
- Fracture, Trauma, Ulna Fracture, Orthopedic, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Orthopaedic Research Legacy, Canadian Orthopaedic Trauma Society, Calgary Surgical Research Development Fund, AO Research Fund
- Study start
- 2 Jul 2010 (actual)
- Primary completion
- 8 Mar 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: Open reduction and internal fixationIsolated 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. |
| Short arm cast | Active comparator | Procedure: Closed reduction and short-arm castThose individuals randomized to the non-operative treatment group will be treated with a closed reduction and short-arm (below-elbow) cast. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction and internal fixationAlso: Limited contact dynamic compression plate (LC-DC) with screw fixationPatients will undergo surgery for open reduction of the fracture and internal fixation with an LC-DC plate and screw fixation. | Procedure or surgery | Surgery |
| Closed reduction and short-arm castPatient will undergo a closed reduction and be placed in a short-arm (below-elbow) cast for 6 weeks. | Procedure or surgery | Short arm cast |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (The DASH)
Time frame: 1 year
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
6 secondary outcomes
Range of Motion
Time frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Grip Strength
Time frame: 6 weeks, 12 weeks, 6 months, 12 months
Radiologic outcome - time to union (fracture healing)
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
SF-36
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Pain Visual Analogue Score
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
DASH score
Time frame: baseline, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
Related trials for Fracture
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Duffy, MD principal investigator
University of Calgary
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and internal fixation and Closed reduction and short-arm cast in people with Fracture and Trauma, run by University of Calgary at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (The DASH) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.