A02.835.232.087.090.400.400
Conditions
Keywords
Fracture-luxation, humeral proximal extremity, Hemiarthroplasty, reverse Arthroplasty
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of Neer's classification.
Detailed description
Proximal extremity humeral fractures present high prevalence. It's estimated about 10% of all fractures. Their incidence is 6,6/1000 people-year and this amount increases from 40 years old. The majority are successfully treated with immobilization and rehabilitation. The surgical treatment is recommended in case of displacement. In elderly population with fractures types three or four of Neer's classification there is no consensus on which technique is the best surgical option. Classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. Recently some authors recommend the reverse arthroplasty in patients over 70 years old . The aim of this study is to compare the results between Hemiarthroplasty and reverse arthroplasty in patients over 70 years old. As far as the investigators are concerned there's no published studies like this.
Interventions
PROCEDUREHemiarthroplasty
PROCEDUREreverse arthroplasty
Sponsors
Carlos Alvarez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of Neer's classification. * Patient 70 years older * Signed informed consent.
Exclusion criteria
* Any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology…) * Glenohumeral osteoarthritis * Inflammatory arthropathies * Previous cuff arthropatyy * High surgical or anesthesia risk * Any disease or condition that the investigator finds decisive for exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score | 36 months | changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. |
| Effectiveness Will be Measured for Constant Score | 36 months | changes in Constant score will be measured. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. |
| Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score | 36 months | changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemiarthroplasty Global Fx(DePuy) in this technique the prosthesis is implanted in similar approach to shoulder anatomy
Hemiarthroplasty | 20 |
| Reverse Arthroplasty Delta Xtent(DePuy) In this technique the prosthesis is implanted in the inverse mode of shoulder anatomy
reverse arthroplasty | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Reverse Arthroplasty Delta Xtent(DePuy) | Total | Hemiarthroplasty Global Fx(DePuy) |
|---|---|---|---|
| Age, Continuous | 77 years | 76 years | 76 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Spain | 19 participants | 39 participants | 20 participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score
changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hemiarthroplasty Global Fx(DePuy) | Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score | 66 score on a scale |
| Reverse Arthroplasty Delta Xtent(DePuy) | Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score | 77 score on a scale |
p-value: 0.048Mixed Models Analysis
Primary
Effectiveness Will be Measured for Constant Score
changes in Constant score will be measured. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hemiarthroplasty Global Fx(DePuy) | Effectiveness Will be Measured for Constant Score | 53 score on a scale |
| Reverse Arthroplasty Delta Xtent(DePuy) | Effectiveness Will be Measured for Constant Score | 70 score on a scale |
p-value: 0.001Mixed Models Analysis
Primary
Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score
changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)
Time frame: 36 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hemiarthroplasty Global Fx(DePuy) | Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score | 26 score on a scale |
| Reverse Arthroplasty Delta Xtent(DePuy) | Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score | 13 score on a scale |
p-value: 0.011Mixed Models Analysis