Study Comparing Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01123447|
Recruitment Status : Recruiting
First Posted : May 14, 2010
Last Update Posted : August 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fracture Trauma Ulna Fracture Orthopedic Surgery||Procedure: Open reduction and internal fixation Procedure: Closed reduction and short-arm cast||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial Comparing Open Reduction and Internal Fixation With Non-operative Treatment for Ulnar Shaft Fractures|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Surgery
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
Patients will undergo surgery for open reduction of the fracture and internal fixation with an LC-DC plate and screw fixation.
Other Name: Limited contact dynamic compression plate (LC-DC) with screw fixation
Active Comparator: Short arm cast
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
Patient will undergo a closed reduction and be placed in a short-arm (below-elbow) cast for 6 weeks.
- Disabilities of the Arm, Shoulder and Hand (The DASH) [ Time Frame: 1 year ]
- Range of Motion [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year ]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.
- Grip Strength [ Time Frame: 6 weeks, 12 weeks, 6 months, 1 year ]An evaluation of the grip strength for both the affected limb and the unaffected limb post-treatment.
- Radiologic outcome - time to union (fracture healing) [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year ]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.
- SF-36 [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year ]
- Pain Visual Analogue Score [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year ]
- DASH score [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123447
|Contact: Kimberly D Carcary, MScemail@example.com|
|Contact: Prism S Schneider, MD, PhDfirstname.lastname@example.org|
|Dr. Paul J Duffy||Recruiting|
|Calgary, Alberta, Canada, T2N 2T9|
|Contact: Kimberly Carcary, MSc 403.944.2932 email@example.com|
|Sub-Investigator: Buckley Richard, MD|
|Sub-Investigator: Korley Robert, MD|
|Sub-Investigator: Puloski Shannon, MD|
|Canada, British Columbia|
|Royal Columbian Hospital||Recruiting|
|New Westminster, British Columbia, Canada|
|Contact: Mauri Zomar firstname.lastname@example.org|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Jessica Peattie email@example.com|
|Canada, Newfoundland and Labrador|
|St. John's, Newfoundland and Labrador, Canada|
|Contact: Minnie Parsons firstname.lastname@example.org|
|Canada, Nova Scotia|
|Queen Elizabeth II Hospital||Recruiting|
|Halifax, Nova Scotia, Canada|
|Contact: Kelly Trask email@example.com|
|Ottawa, Ontario, Canada|
|Contact: Julia Foxall firstname.lastname@example.org|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Milena (Lynn) Vicente email@example.com|
|McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada|
|Contact: Fiona Houghton firstname.lastname@example.org|
|University of Saskatoon||Recruiting|
|Saskatoon, Saskatchewan, Canada|
|Contact: Elliott Pally email@example.com|
|North Bristol NHS Trust||Recruiting|
|Bristol, United Kingdom|
|Contact: Steven Barnfield firstname.lastname@example.org|
|Principal Investigator:||Paul J Duffy, MD||University of Calgary|