Humeral Shaft Fractures: Measuring Recovery after Operative versus Non-operative Treatment (HUMMER): A multicenter comparative observational study.|
|- candidate number||13331|
|- NTR Number||NTR3617|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-sep-2012|
|- Secondary IDs||2012-396 METC ErasmusMC|
|- Public Title||Humeral Shaft Fractures: Measuring Recovery after Operative versus Non-operative Treatment (HUMMER): A multicenter comparative observational study.|
|- Scientific Title||Humeral Shaft Fractures: Measuring Recovery after Operative versus Non-operative Treatment (HUMMER): A multicenter comparative observational study.|
|- hypothesis||At one year post-injury, the DASH score is expected to be similar in both groups, however, improved DASH scores are expected to be noticeable between six weeks and six months after treatment initiation, reflecting a faster functional recovery for the operative treatment group. Operative treatment of a humeral shaft fracture results in reduced nonunion rates compared with non-operative treatment. Despite higher initial costs of surgery, we expect operative treatment to be more cost-effective than non-operative treatment. Patients will be able to resume work faster, and (elderly) patients are expected to regain independence sooner.|
|- Healt Condition(s) or Problem(s) studied||Humeral fractures|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||31-dec-2015|
|- Target number of participants||400|
|- Interventions||1. Operative treatment;|
2. Non-operative treatment.
|- Primary outcome||DASH (Disabilities of the Arm, Shoulder, and Hand) score.|
|- Secondary outcome||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);
|- Timepoints||Baseline, 2 weeks, 6 weeks, 3 months, 6 months and 12 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. D. Hartog, den|
|- CONTACT for SCIENTIFIC QUERIES||MD. D. Hartog, den|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Surgery-Traumatology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Surgery-Traumatology|
|- Brief summary||BACKGROUND:|
Fractures of the humeral shaft account for 1-3% of all fractures, and approximately 20% of all humeral fractures. The annual cumulative incidence is 14.5 per 100,000 persons, gradually increasing from the fifth decade and reaching a peak of 60 per 100,000 persons in the ninth decade.
Fractures of the humeral shaft can be treated operatively or non-operatively. Operative treatment is mostly done by intramedullary nailing, plate osteosynthesis, or external fixation. Non-operative treatment can vary from a functional (Sarmiento) brace to plaster. The operative and non-operative treatment strategies both have their pros and cons, and there is currently insufficient data in the literature to support which type of treatment gives the best (clinical and functional) result. This study is aimed at answering this question.
The primary objective of this study is to examine the effect of operative versus non-operative treatment on the DASH (Disabilities of the Arm, Shoulder, and Hand) score, reflecting functional outcome and pain of the upper extremity, in adult patients who sustained a humeral shaft fracture. Secondary aims are to assess effects on functional outcome, pain, range of motion, rates of complication and secondary interventions, resumption of work and ADL, and quality of life in these patients. The costs and cost-effectiveness of both interventions will be determined.
Multi-center observational clinical study. Approximately 26 hospitals in the Netherlands will participate.
Patients aged 18 years or older with a humeral shaft fracture (AO types 12A1-3 or 12B1-3).
The decision on treatment will be left at the discretion of the attending surgeon.
Operative treatment group: The choice between plate osteosynthesis or intramedullary nailing will be left to the treating surgeon. Patients treated with an external fixator will be excluded due to the indications for using such a type of fixation. Critical elements of the operation (e.g., type of implant, identification of the radial nerve, surgical approach, operative delay, duration of surgery) will be recorded but not standardized.
Non-operative treatment group: In order to maximize generalizability, the type of non-operative treatment will be left to the attending surgeon. Usually it consists of a splint, plaster, or a Sarmiento brace with initially collar and cuff for at least 1-2 weeks. Critical elements of this treatment will be recorded but not standardized.
Due to a lack of evidence favoring a particular approach, the physical therapy and rehabilitation program will be recorded but not standardized. This allows for post-hoc analysis and improves generalization of the study results.
Primary outcome (DASH) and secondary outcomes (Constant score, pain, ROM, secondary intervention rates, complication rates, resumption of work and ADL, SF-36, and EQ-5D) will be compared at baseline, at 2 and 6 weeks, and at 3, 6, and 12 months after start of treatment, using both univariate and multivariable analyses. Costs for (in)formal healthcare consumption will be determined for both interventions, cost-effectiveness will be expressed as cost per quality of life year (QALY) gained.
|- Main changes (audit trail)|
|- RECORD||18-sep-2012 - 27-sep-2012|
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