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

Browse trials for

• Finger Injuries 24
• Amputation, Traumatic 112

Keywords

• finger amputation
• single finger amputation
• single digit amputation

Finger Injuries

24 studies on the registry are indexed under Finger Injuries; 4 are open to participants now.

This study's planned enrollment of 252 is above the median of 33 across 19 interventional studies indexed under Finger Injuries.

Lead sponsor

Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.

Study arms

• Active comparator
  Tamai zone 1 operative

  operative treatment of surgeons choice

  Procedure: Operative treatment of surgeons choice

• Experimental
  Tamai Zone 1 non-operative

  treatment with semi-occlusive film

  Procedure: Semi-occlusive film

• Active comparator
  Tamai zone 2 operative

  Operative treatment of surgeons choice

  Procedure: Operative treatment of surgeons choice

• Experimental
  Tamai Zone 2 non-operative

  treatment with semi-occlusive film

  Procedure: Semi-occlusive film

• Active comparator
  Tamai Zone 3-4 operative (fingers II-V)

  Operative treatment of surgeons choice

  Procedure: Operative treatment of surgeons choice

• Experimental
  Tamai Zone 3-4 non-operative (fingers II-V)

  treatment with semi-occlusive film

  Procedure: Semi-occlusive film

Interventions

• ProcedureOperative treatment of surgeons choice

  treatment of single finger amputation with revision amputation, local or micro-vascular flap as best befits each specific injury

• ProcedureSemi-occlusive film

  The film is placed on a cleansed wound surface. bone is shortened to the level of injury. Visible nerves, arteries and tendons are cut and allowed to retract. The film is to be changed once weekly until the wound has closed.

Primary outcomes

1. PRWHE

   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.

   Time frame: 12 months

Secondary outcomes

1. PRWHE 1 month

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

   Time frame: 1 month

2. PRWHE 3 months

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

   Time frame: 3 months

3. PRWHE 6 months

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

   Time frame: 6 months

4. Return to daily activities 1 month

   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.

   Time frame: 1 month

5. Return to daily activities 3 months

   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.

   Time frame: 3 months

6. Return to daily activities 6 months

   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.

   Time frame: 6 months

7. Return to daily activities 12 months

   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.

   Time frame: 12 months

8. Michigan Hand Questionnaire (MHQ) aesthetics subsection 6 months

   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.

   Time frame: 6 months

9. Michigan Hand Questionnaire (MHQ) aesthetics subsection 12 months

   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.

   Time frame: 12 months

10. Cold Intolerance Symptom Severity (CISS) 6 months

    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.

    Time frame: 6 months

11. Cold Intolerance Symptom Severity (CISS) 12 months

    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.

    Time frame: 12 months

12. Patient Accepted Symptom State (PASS) 1 month

    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

    Time frame: 1 month

13. Patient Accepted Symptom State (PASS) 3 months

    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

    Time frame: 3 months

14. Patient Accepted Symptom State (PASS) 6 months

    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

    Time frame: 6 months

15. Patient Accepted Symptom State (PASS) 12 months

    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

    Time frame: 12 months

16. Standard two-point discrimination

    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.

    Time frame: 12 months

17. Moberg pick up test (MPUT)

    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.

    Time frame: 12 months

18. Range of motion (ROM)

    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.

    Time frame: 12 months

19. Grip strength

    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.

    Time frame: 12 months

20. Difference in bony length

    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

    Time frame: 12 months

Individual participant data

Plan to share: Yes — Individual participant data is going to be analysed in pseudonymised form. Data can be shared outside the study group but within the EU and EEA area for this study's statistical analysis purpose only. The Data Safety Monitoring Committee has the right to review the data collected in the study and check that the study has been carried out in an appropriate manner. Individual participants cannot be recognized from the published results. The results are going to be published in peer-reviewed international medical journals. Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes. No Identifying data will be shared outside the study group for any reason.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Study protocol will be published in an appropriate journal and it and ICF and SAP will be available from the publication date onward. Other IPD as described above will be available after the completion of the study.

Access criteria: Summary statistics may be shared outside the study group if reasonable request is received - for example, for meta analysis purposes.