Proximal Humerus Fractures Randomized Control Trial
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02362100|
Recruitment Status : Terminated (Due to low recruitment, lack of funding, and challenges maintaining follow-up in this patient population, a decision was made to terminate this study.)
First Posted : February 12, 2015
Last Update Posted : May 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Proximal Humerus Fracture||Other: Non operative Procedure: locking plate surgical fixation||Not Applicable|
The design of this study is two-fold. The main study will be a prospective, single blind, randomized controlled trial (RCT). Patients will be randomized to either (1) non-operative treatment or (2) locking plate open reduction and internal fixation (ORIF).
The second component of this study will be a prospective, cohort study. This option will be presented to patients who do not want to enroll in the RCT because they prefer one treatment option over the other, and do not wish to be randomized to a treatment. Patients who choose either non-operative treatment or ORIF for their proximal humerus fracture will be followed for 2 years post injury.
Objective 1: Does a difference exist in the functional outcome between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the Constant functional outcome score over a 2-year follow-up period? Objective 2: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on the ASES functional outcome score, the short form Patient Reported Outcomes Measurement Information System (PROMIS) upper extremity score, the International Physical Activity Questionnaire (IPAQ) for the elderly, and the EuroQol EQ-5D-5L Health Questionnaire Quality of Life (QoL) functional outcome score over a 2-year follow-up period? What is the incidence of complications of non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on infection, nerve injury, intra-articular screw penetration and bleeding (hematoma), reoperation rate, or hospital readmission over a 2-year follow-up period? Objective 3: Does a difference exist between non-operative management and locking plate surgical fixation of low-energy displaced two-part, three-part, and four-part proximal humerus fractures in the elderly population based on radiographic outcomes including non-union, malunion, and joint arthrosis? Objective 4: Does the degree of initial displacement or angulation of the fracture fragments correlate with final functional outcome measures? Objective 5: Does the quality of the surgical reduction correlate with final functional outcome measures?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Proximal Humerus Fractures Randomized Control Trial|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 2021|
|Actual Study Completion Date :||January 2021|
Placebo Comparator: nonoperative management
Treatment will consist of sling immobilization for a period of 6 weeks. Details and treatment timeline as follows:
Other: Non operative
non operative treatment
Active Comparator: locking plate surgical fixation
Standardized operative management protocol as follows:
Procedure: locking plate surgical fixation
- Change in Constant Score [ Time Frame: From baseline to up until 24-Months Post-Operative ]The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
- Change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment [ Time Frame: From baseline to up until 24-Months Post-Operative ]The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
- Change in Short Form-36 [ Time Frame: From baseline to up until 24-Months Post-Operative ]The Short Form 36 (SF-36) is an outcome measure used to determine quality of life. This measure has 8 scaled scores, each question has equal weight and is then translated onto a scale graded from 0-100. A higher number indicates a better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362100
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H8L6|
|Principal Investigator:||Peter Lapner, MD||The Ottawa Hospital|