Operative Treatment vs Treatment With Semi-occlusive Dressing for Single Finger Amputations

Our primary outcome measure is PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 12 months post-randomization. Patient-Reported Wrist and Hand Evaluation (PRWHE) was chosen, because it covers both pain and loss of function which are the main symptoms after a digital amputation, has evidence of reliability, validity and responsiveness in hand and wrist trauma population, and is considered slightly more responsive than DASH. As a patient reported outcome, it is prone to ascertainment bias - especially since in this study setting it is not possible to blind the participant to given treatment. To overcome this, we have included several objective outcome measures as secondary outcomes. Nevertheless, Patient-Reported Outcome Measures are considered the most meaningful instruments for outcome evaluation in musculoskeletal conditions, because those assess patient-perceived important symptoms and disability.

PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 1 month post-randomization.

PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 3 months post-randomization.

PRWHE mean difference (MD) between treatment arms in each stratum with the associated 95% confidence interval (CI) at 6 months post-randomization.

return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.

return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.

return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.

return to daily activities is collected at 1, 3, 6, and 12 months. Amputation injuries are significant indicators for being off work and having a prolonged time off work. Potential difference between treatment arms in Return to ordinary daily activities could have wider economic implications and work as a factor in determining the most beneficial treatment option for each patient.

MHQ aesthetics subsection will be collected at 6 and 12 months. We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Reliability, validity, and responsiveness of the MHQ is well-documented. Aesthetics is of interest to measure patient satisfaction with more than pain or function focused questionnaires.

MHQ aesthetics subsection will be collected at 6 and 12 months. We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Reliability, validity, and responsiveness of the MHQ is well-documented. Aesthetics is of interest to measure patient satisfaction with more than pain or function focused questionnaires.

We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Cold intolerance is recognized as a disabling sequelae of upper extremity trauma, especially when neurovascular structures are involved. CISS test score ranges between a minimum of 4 and a maximum of 100, where lower is better.

We will analyse a MD between treatment arms in each stratum with the associated 95% CI. Cold intolerance is recognized as a disabling sequelae of upper extremity trauma, especially when neurovascular structures are involved. CISS test score ranges between a minimum of 4 and a maximum of 100, where lower is better.

PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity

PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity

PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity

PASS is collected at 1, 3, 6 and 12 months. PASS will be assessed with the statement, "I am satisfied with the pain level and function of my finger/thumb," rated on a 5-point Likert scale (strongly disagree, somewhat disagree, neither agree nor disagree, somewhat agree, strongly agree). We will also assess whether the patients would choose the same treatment again with the statement "If I would be in the same circumstances, I would be willing to undergo this treatment again" rated on the same 5-point Likert scale as the previous statement. Results will be dichotomized between 'neither agree nor disagree' and 'somewhat agree' for both statements. This type of questionnaire has been shown to have good test-retest reliability and construct validity

Tests evaluating finger pulp sensitivity are frequently used in clinical practice. S2PD has been used in many digital nerve repair studies, and has good test retest and interobserver reliability, although has received criticism for lack of standardization in previous studies. S2PD normative results depend on the age of the patients, being close to 2mm in younger patients and around 4mm in elderly population. Generally, the lower the result, the better sensation is in the fingertip.

MPUT is a standardized test designed to evaluate hand dexterity. Fine motor dexterity of the hand can be affected by disruptions in sensation of fingertips, meriting use of this outcome measure for this study. MPUT normative data depends on the age of the patient and is approximately 12 seconds for young patients (20-39yo) and 16-17 seconds for elderly patients (60+yo). Generally, the lower the result, the better.

ROM is measured to reveal whether the remaining joints of the affected digit are regaining mobility or if there are limitations due to scar tissue, contractures, or stiffness. The functional range of motion is 19°-71° at the metacarpophalangeal, 23°-87° at proximal interphalangeal, and 10°-64° at distal interphalangeal joints.

Grip strength is measured using Jamar dynamometer, providing standardized, reliable data for comparisons. The closer the result is to that of the uninjured hand, the better.

X-rays are taken from the affected hand at baseline before any interventions and at 12-month follow-up to measure potential changes in bony length of the affected digit between treatment arms of each stratum