K-wire fixation with direct moBilization versus Open Reposition anD intErnal fixation with direct mobilizAtion in Unstable proXimal phalangeal shaft fractures.

Function, pain and disability expressed as change during the first 3 months on

the Michigan Hand Questionnaire Score (MHQ-DLV) measured at randomization and

one, four weeks and 3 months post-operative The MHQ is a validated tool for

assessing functional outcome in patients with complaints of the hand5,8. The

MHQ is a questionnaire divided in six subscales; overall hand function,

activities of daily living (ADLs), pain, work performance, aesthetics and

patient satisfaction with hand function. Each subscale has a formula to

calculate a score from 0 (severe disability) to 100 (no disability). The final

score is a summation of the six individual item-scores divided by six and

ranges from 0 (severe disability) to 100 (no disability).

- Function, pain and disability expressed on the Michigan Hand Questionnaire

Score (MHQ). Therefore MHQ-score will be measured at twelve months

post-operative.

- Disability, expressed on Patient Specific Functional and pain Scales (PSFS)

at randomization and one, four weeks, three, twelve months post-operative. 9.

The PSFS is a list of 3-5 self-chosen activities, scored from 0 (difficult to

preform activity) to 10 (no difficulty to preform activity). The final score

goes from 0 (severe difficulty) tot 10 (no difficulty) and is a summation of

the activity scores divided by the number of activities.

- Health literacy; the ability of an individual to access, understand, and use

health-related information and services to make appropriate health decisions,

with the Newest Vital Sign- Dutch langue version (NVS-D)10. The NVS-D is a

6-item questionnaire where a score of 4 or more right answers distinguish

individuals with adequate versus inadequate health literacy. The NVS-D will be

measured ones, an out-patient clinic appointment, preferably at randomization.

- Overall patient satisfaction (of the injury of the hand), on Visual Analogue

Satisfaction Scale, scored from 0 (very dissatisfied) to 10 (completely

satisfied), measured at randomization and one, four weeks, three, six and

twelve months post-operative. - Overall patient satisfaction (of the injury of

the hand), on a 5 point scale from -2 (very dissatisfied) to +2 (completely

satisfied) measured at randomization and one, four weeks, three, six and twelve

months post-operative.

- Patient satisfaction about improvement of function of the finger between the

operation and three months with the Visual Analogue Satisfaction Scale, scored

from 0 (very dissatisfied) -to 10 (completely satisfied), measured at three

months and patient satisfaction about improvement of function of the finger

between three months and twelve months with the Visual Analogue Satisfaction

Scale, scored from 0 (very dissatisfied) to 10 (completely satisfied),

measured at twelve months.

- Patient satisfaction about improvement of function of the finger between

operation and three months on a 5 point scale from -2 (no improvement) to +2

(completely improved), measured at three and patient satisfaction of

improvement of function of the finger between three and twelve months on a 5

point scale from -2 (no improvement) to +2 (completely improved), measured at

twelve months.

- Patient satisfaction about improvement of pain of the finger between

operation and 3 months on a 5 point scale from -2 (no improvement) to +2

(completely improved), measured at three months and patient satisfaction of

improvement of pain of the finger between three and twelve months on a 5 point

scale from -2 (no improvement) to +2 (completely improved), measured at twelve

months.

- Patient satisfaction on improvement of disability of the finger between

operation and 3 months on a 5 point scale from -2 (no improvement) to- +2

(completely improved), measured at three months and patient satisfaction on

improvement of disability of the finger between three and twelve months on a 5

point scale from -2 (no improvement) to +2 (completely improved), measured at

twelve months.

- Patient satisfaction on aesthetics of the finger over the last 3 months on a

5 point scale from -2 (no improvement) to +2 (completely improved), measured at

three months and patient satisfaction on aesthetics of the finger between three

and twelve months on a 5 point scale from -2 (no improvement) to +2 (completely

improved), measured at twelve months.

- Patient satisfaction on work performance over the last 3 months on a 5 point

scale from -2 (no improvement) to +2 (completely improved), measured at three

months and patient satisfaction on work performance between three and twelve

months on a 5 point scale from -2 (no improvement) to +2 (completely improved),

measured at twelve months.

- Overall satisfaction of the finger over the last 3 months on a 5 point scale

from -2 (no improvement) to +2 (completely improved), measured at three months

and overall satisfaction of the finger between three and twelve months on a 5

point scale from -2 (no improvement) to +2 (completely improved), measured at

twelve months.

- Pain as indicated on a Visual Analogue Scale (VAS), where 0 implies no pain

and 10 the worst possible pain, measured at randomization and one, four weeks,

three, six and twelve months post-operative.

- Patient-expectation; Pre-consultation expectation of the patient on recovery

and post-consultation achievement of this expectation. At the first outpatient

clinic visit (at randomization) patients will be asked what they expect to

achieve in degree of improvement and restriction at a five-point scale; 1. No

improvement, full restriction; 2. Slight improvement, serious restriction; 3.

Moderate improvement, moderate restriction; 4. Substantial improvement, slight

restriction; 5. Complete improvement, no restriction.

At the last outpatient clinic visit (in general at three months) patients will

be asked to re-answer this question. Achievement of expectation is expressed as

the difference between their answer of the pre-and -post consultation

questions. At twelve months patients will be asked to re-answer this question.

Achievement of expectation is expressed as the difference between their answer

of the pre consultation question and end of the study question.

- Total active motion (TAM) = Active Range Of Motion of the

metacarpal-phalangeal joint, the proximal interphalangeal joint and the distal

interphalangeal joint minus any extension deficits. TAM is measured at

randomization and one, four weeks and three months post-operative11.



Range of motion (ROM) of the wrist measured on both sides with a handheld

goniometer. ROM includes pronation and supination, ulnar and radial deviation

and palmar and dorsal flexion of the wrist. ROM is measured at randomization

and one, four weeks and three months postoperative.

- Health care costs, productivity losses and out-of-pocket expenses with the

adapted Dutch iMTA Medical Consumption Questionnaire and iMTA Productivity Cost

Questionnaire (see economic evaluation below), measured at four weeks, three,

six and twelve months post-operative.

- Measurement of health status with the EQ-5D-5L at randomization and four

weeks, three, six and twelve months post-operative. This questionnaire consists

of 5 items, measuring (at 5-point scales) whether patients experience problems,

and if so, to what extent with regard to mobility, self-care, daily activities,

pain/complaints, and mood.

- Health utility and quality adjusted life-years

- Complications