Closed Fracture Proximal Humerus, Neck Clinical Trial
— HURAOfficial title:
A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures
NCT number | NCT00612391 |
Other study ID # | HURA1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2007 |
Est. completion date | November 2020 |
Verified date | April 2021 |
Source | Université de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. The trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. The Quick DASH will be used for evaluation of function.The study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years
Status | Completed |
Enrollment | 79 |
Est. completion date | November 2020 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Humeral surgical neck fracture, Neer II valgus-type Neer III 2. Patient willing to participate in the study 3. Patient available for follow-up through at least two years 4. Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk 5. Patient fluent in French and/or English and able to understand his/her role in the study Exclusion Criteria: 1. Inflammatory arthritis 2. Prior shoulder pathology 3. Active local or systemic infection 4. Neurologic or musculoskeletal disease that may adversely affect mobility 5. Participation in any other pharmaceutical, biologic or medical-device clinical investigation 6. Severe documented psychiatric disease 7. Severe ipsilateral elbow or wrist disease 8. Fracture resistant to reduction attempts through the minimally invasive lateral approach |
Country | Name | City | State |
---|---|---|---|
Canada | Hopital Sacré-Coeur | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Montréal | Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Hopital du Sacre-Coeur de Montreal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quick DASH | 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months. | ||
Secondary | SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate | 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months. |