Humeral shaft fracture
Conditions
Interventions
1. Operative treatment
2. Non-operative treatment.
Sponsors
Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of Surgery
Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult men or women aged 18 years and older (with no upper age limit); 2. A fracture of the humeral shaft, AO class 12A or 12B (confirmed on X-ray); 3. Operation within 14 days after presentation to the ED (if this is the treatment of choice); 4. Provision of informed consent by patient.
Exclusion criteria
Exclusion criteria: 1. Polytraumatized patients affecting treatment and rehabilitation of the affected arm; 2. Patients treated with an external fixator; 3. Patients with pathological, recurrent or open humeral shaft fracture; 4. Patients with neurovascular injuries requiring immediate surgery (excl. radial nerve palsy); 5. Additional traumatic injuries of the affected arm that influence upper extremity function; 6. Patients with an impaired upper extremity function (i.e., stiff or painful arm or neurological disorder of the upper limb) prior to the injury; 7. Retained hardware around the affected humerus; 8. Patients with rheumatoid arthritis; 9. Bone disorder which may impair bone healing (excluding osteoporosis); 10. Patients incapable of ensuring follow-up (e.g., no fixed address or cognitive impairment); 11. Insufficient comprehension of the Dutch language to understand the rehabilitation program and other treatment information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DASH (Disabilities of the Arm, Shoulder, and Hand) score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Constant score; 2. Pain level (VAS); 3. Range of Motion of the shoulder and elbow joints; 4. Rate of complications; 5. Rate of secondary interventions; 6. Time to resumption of work and activities of daily living; 7. Health-related quality of life (SF-36 and EQ-5D); 8. Costs; 9. Cost-effectiveness. | — |
Contacts
Public ContactD. Hartog, den
Erasmus MC, dept. of Surgery-Traumatology Mailbox H-822k 's-Gravendijkwal 230, 3015 CE Rotterdam P.O. Box 2040
Outcome results
None listed