Proximal Humeral Fractures
Conditions
Keywords
proximal humerus fracture, rehabilitation, non-operative treatment, DASH and Constant instruments
Brief summary
The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.
Detailed description
Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.
Interventions
None listed
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and Female patients. * Any race * Older than 18y * Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans. * Any type of proximal humeral fracture according to the Neer or AO classification system. * Patient should have received non-operative treatment.
Exclusion criteria
* Patients younger than 18 y. * Patients with multiple other fractures. * Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Flexion | 6 months | We measured active forward flexion of the shoulder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain Likert Scores | 3 months, 6 months | Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain. |
| External Rotation | 3 months, 6 months | — |
| Abduction | 3 months, 6 months | — |
| Disability of the Hand, Shoulder, and Arm Score | 3 months, 6 months | Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Therapy Subjects who begin therapy immediately after diagnosis of injury. | 26 |
| Late Therapy Subjects who delay therapy for 3 weeks after diagnosis of injury. | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 17 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Early Therapy | Late Therapy | Total |
|---|---|---|---|
| Age, Continuous | 63 Years STANDARD_DEVIATION 13 | 62 Years STANDARD_DEVIATION 12 | 63 Years STANDARD_DEVIATION 13 |
| Injured Hand Dominant | 9 Participants | 12 Participants | 21 Participants |
| Injured Hand Non-dominant | 17 Participants | 12 Participants | 29 Participants |
| Non- or minimally displaced No | 4 Participants | 5 Participants | 9 Participants |
| Non- or minimally displaced Yes | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Shoulder Flexion
We measured active forward flexion of the shoulder
Time frame: 6 months
Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Therapy | Shoulder Flexion | 150 Degrees | Standard Deviation 26 |
| Late Therapy | Shoulder Flexion | 146 Degrees | Standard Deviation 22 |
Secondary
Abduction
Time frame: 3 months, 6 months
Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Therapy | Abduction | Abduction, 3 months | 115 Degrees | Standard Deviation 43 |
| Early Therapy | Abduction | Abduction, 6 months | 147 Degrees | Standard Deviation 27 |
| Late Therapy | Abduction | Abduction, 3 months | 101 Degrees | Standard Deviation 41 |
| Late Therapy | Abduction | Abduction, 6 months | 136 Degrees | Standard Deviation 33 |
Secondary
Disability of the Hand, Shoulder, and Arm Score
Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.
Time frame: 3 months, 6 months
Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Therapy | Disability of the Hand, Shoulder, and Arm Score | DASH, 3 months | 33 Units on a scale | Standard Deviation 25 |
| Early Therapy | Disability of the Hand, Shoulder, and Arm Score | DASH, 6 months | 18 Units on a scale | Standard Deviation 12 |
| Late Therapy | Disability of the Hand, Shoulder, and Arm Score | DASH, 3 months | 24 Units on a scale | Standard Deviation 15 |
| Late Therapy | Disability of the Hand, Shoulder, and Arm Score | DASH, 6 months | 14 Units on a scale | Standard Deviation 7 |
Secondary
External Rotation
Time frame: 3 months, 6 months
Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Therapy | External Rotation | External Rotation, 3 months | 53 Degrees | Standard Deviation 30 |
| Early Therapy | External Rotation | External Rotation, 6 months | 70 Degrees | Standard Deviation 17 |
| Late Therapy | External Rotation | External Rotation, 3 months | 51 Degrees | Standard Deviation 21 |
| Late Therapy | External Rotation | External Rotation, 6 months | 66 Degrees | Standard Deviation 26 |
Secondary
Shoulder Pain Likert Scores
Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.
Time frame: 3 months, 6 months
Population: All analysis conducted with those who completed 3-month follow-up. We used mean imputation for the 6-month evaluation for patients who did not attend a 6-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Therapy | Shoulder Pain Likert Scores | NRS Pain, 3 months | 3 units on a scale | Standard Deviation 2 |
| Early Therapy | Shoulder Pain Likert Scores | NRS Pain, 6 months | 2 units on a scale | Standard Deviation 1 |
| Late Therapy | Shoulder Pain Likert Scores | NRS Pain, 3 months | 3 units on a scale | Standard Deviation 1 |
| Late Therapy | Shoulder Pain Likert Scores | NRS Pain, 6 months | 2 units on a scale | Standard Deviation 3 |