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出境医 / 临床实验 / Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures

Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures

Study Description
Brief Summary:
There is a lack of strong evidence guiding the treatment of non-thumb isolated closed metacarpal shaft fractures towards operative fixation versus conservative management. Surgical approach is largely decided by surgeon preference/skill, qualities of fracture, and extent of injury. Previous studies have shown that many metacarpal fractures can be treated non-operatively, with outcomes being as good as or better than those treated with surgery. Surgery using plates can often cause stiffness, contractures, and in rare causes nonunion infection or tendon rupture. This study will seek to build upon previous evidence to help guide future surgeons as they decide how to approach a closed non-thumb metacarpal fractures. Patients will be identified in clinic after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the non-operative or surgical group. This decision will be done through randomization.The investigators anticipate that 100 subjects will be enrolled. Patient reported outcomes, including the PROMIS forms, Disabilities of the Arm, Shoulder and Hand (DASH) surveys and Visual Analog Scale (VAS) will be recorded. Range of motion will be assessed at all time points along with grip strength. X-rays will be evaluated for metacarpal shortening, rotation or non-union. In addition, time for clinical and radiologic union will be documented.

Condition or disease Intervention/treatment Phase
Metacarpal Fracture Procedure: Surgical Fixation Other: Non-Operative Management Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures, A Randomized Controlled Trial
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : January 20, 2029
Estimated Study Completion Date : January 20, 2035
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Non-operatively
  1. Adults 18 and older
  2. Native English-speaker
  3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)
Procedure: Surgical Fixation
For both scissoring and non-scissoring injuries surgical fixation by either pinning, dorsal plate, or lag screws will be considered. This will be determined by surgeon expertise at the time of surgical fixation. Postoperative, a volar short arm splint and immediate AROM at full range with buddy taping to adjacent digit will be indicated. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.
Other Name: Fracture Fixation

Active Comparator: Surgical
  1. Adults 18 and older
  2. Native English-speaker
  3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)
Other: Non-Operative Management
  1. For non-scissoring injuries: Placement of short-arm cast; immediate AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union.
  2. For scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union
Other Name: Conservative Management

Outcome Measures
Primary Outcome Measures :
  1. Vas Pain Score [ Time Frame: 6 months ]
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 being "no pain" and 10 being "worst pain."

  2. PROMIS score [ Time Frame: 6 months ]
    The Patient-Reported Outcomes Measurement Information System® (PROMIS) is a flexible set of tools designed to measure self-reported physical, mental and social health and wellbeing. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The questionarie assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores are calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).

  3. Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 months ]
    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  4. Grip Strength [ Time Frame: 6 months ]
    Grip strength will be measured using a Hand Dynamometer with the participants seated, their elbow by their side and flexed to right angles, and a neutral wrist position, the dynamometer handle position II and provision of support underneath the dynamometer. Pressure will be reported in pounds / Kilograms of pressure

  5. Extension lag [ Time Frame: 6 months ]
    Measured with a goniometer and expressed in degrees (°)

  6. Finger Range of Motion [ Time Frame: 6 months ]
    Measured with a goniometer and expressed in degrees (°)

  7. Time to union [ Time Frame: 6 months ]
    Time to achieve clinical and radiologic formation of a stable callus, documented in days

  8. Adverse events [ Time Frame: 6 months ]

    Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to:

    Severity; Unanticipated Adverse Device Effect (UADE) Seriousness (Serious Adverse Event (SAE), Non-serious AE); Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 and older
  • Native English-speaker
  • Non-thumb isolated single metacarpal shaft closed fracture

Exclusion Criteria:

  • Pre-existing condition in the involved hand/wrist, hand contracture or deformity, pre-existing stiffness
  • Cognitive dysfunction with inability to follow rehabilitation protocol
  • Subacute/chronic fracture (>4 weeks)
  • Pregnant Participants
  • VA patients
Contacts and Locations

Contacts
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Contact: Stacee Clawson 573-884-9017 clawsons@health.missouri.edu
Contact: Lauren Livesay livesayl@health.missouri.edu

Locations
Layout table for location information
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Sebastian Lalonde, MD University of Missouri-Columbia
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE June 12, 2019
Estimated Primary Completion Date January 20, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Vas Pain Score [ Time Frame: 6 months ]
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 being "no pain" and 10 being "worst pain."
  • PROMIS score [ Time Frame: 6 months ]
    The Patient-Reported Outcomes Measurement Information System® (PROMIS) is a flexible set of tools designed to measure self-reported physical, mental and social health and wellbeing. PROMIS instruments contain a fixed number of items from seven PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. The questionarie assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. Norm-based scores are calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 months ]
    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
  • Grip Strength [ Time Frame: 6 months ]
    Grip strength will be measured using a Hand Dynamometer with the participants seated, their elbow by their side and flexed to right angles, and a neutral wrist position, the dynamometer handle position II and provision of support underneath the dynamometer. Pressure will be reported in pounds / Kilograms of pressure
  • Extension lag [ Time Frame: 6 months ]
    Measured with a goniometer and expressed in degrees (°)
  • Finger Range of Motion [ Time Frame: 6 months ]
    Measured with a goniometer and expressed in degrees (°)
  • Time to union [ Time Frame: 6 months ]
    Time to achieve clinical and radiologic formation of a stable callus, documented in days
  • Adverse events [ Time Frame: 6 months ]
    Adverse Events by type over time, severity, seriousness, and relatedness. AEs will be tabulated and summarized as counts and percentages. AEs will also be cross-tabulated according to: Severity; Unanticipated Adverse Device Effect (UADE) Seriousness (Serious Adverse Event (SAE), Non-serious AE); Device-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related); Procedure-Relatedness (Unrelated, Possibly Related, Probably Related, Definitely Related).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures
Official Title  ICMJE Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures, A Randomized Controlled Trial
Brief Summary There is a lack of strong evidence guiding the treatment of non-thumb isolated closed metacarpal shaft fractures towards operative fixation versus conservative management. Surgical approach is largely decided by surgeon preference/skill, qualities of fracture, and extent of injury. Previous studies have shown that many metacarpal fractures can be treated non-operatively, with outcomes being as good as or better than those treated with surgery. Surgery using plates can often cause stiffness, contractures, and in rare causes nonunion infection or tendon rupture. This study will seek to build upon previous evidence to help guide future surgeons as they decide how to approach a closed non-thumb metacarpal fractures. Patients will be identified in clinic after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the non-operative or surgical group. This decision will be done through randomization.The investigators anticipate that 100 subjects will be enrolled. Patient reported outcomes, including the PROMIS forms, Disabilities of the Arm, Shoulder and Hand (DASH) surveys and Visual Analog Scale (VAS) will be recorded. Range of motion will be assessed at all time points along with grip strength. X-rays will be evaluated for metacarpal shortening, rotation or non-union. In addition, time for clinical and radiologic union will be documented.
Detailed Description

Research Objectives:

The goal of this study is to compare the treatment of outcomes for the nonoperative vs. surgical treatment of isolated closed acute non-thumb metacarpal shaft fracture.

a. Primary Measure: i. Functional outcome: Patient Reported Outcomes, including VAS, PROMIS, DASH (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) b. Secondary Measures: i. Grip Strength (6 weeks, 3 months, 6 months) ii. Extensor Lag (degrees) (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) iii. Composite range of motion (pulp to palm distance) (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) iv. Radiographic metacarpal shortening (at each visit) v. Malrotation (scissoring/gapping) (Pre-Op, 2 weeks, 6 weeks, 3 months, 6 months) vi. Timing of clinical union (lack of tenderness on palpation or stress) vii. Timing of radiographic union (bony bridging across fracture site)

Study Design:

  1. Patients will be identified in clinic after x-rays are positive for a non-thumb metacarpal fracture. If they consent to participate in the study, they will be put into either the non-operative or surgical group. This decision will be done through randomization, and the physician will not select which group the patient is in.
  2. Pre-operatively, the patient will have the following standard of care procedures:

    1. Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS),
    2. Radiographic measurement of metacarpal shortening
    3. Range of Motion Measurements
    4. Malrotation (scissoring/gapping) measurement
  3. Pre-operatively, the patient will have the following procedures as research only:

    a. Disabilities of the Arm, Shoulder and Hand survey (DASH)

  4. Surgical Treatment vs. Non-Surgical Treatment Groups

    1. For non-operatively addressed scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range active range of motion with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union.
    2. For non-operatively addressed non-scissoring injuries: Placement of short-arm cast; immediate active range of motion with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union.
    3. For surgical fixation: The surgeon will utilize either pinning, dorsal plate, or lag screws. This will be determined by surgeon expertise while intra-op. Postoperative volar short arm splint, immediate active range of motion at full range with buddy taping to adjacent digit. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.
  5. Post-operatively, the patient will have the following standard of care procedures at the 2 week, 6 week, 3 month and 6 month time points:

    1. Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS)
    2. Radiographic measurement of metacarpal shortening
    3. Range of Motion Measurements
    4. Malrotation (scissoring/gapping) measurement
    5. Grip Strength (at 6 week, 3 month, and 6 month follow-ups only)
    6. Notation of timing of clinical union based upon the lack of tenderness on palpation or stress
    7. Notation of the timing of radiographic union, based on bony bridging across the fracture site
  6. Post-operatively, the patient will have the following research only procedures at the 2 week, 6 week, 3 month and 6 month time points:

    a. Disabilities of the Arm, Shoulder and Hand survey (DASH)

  7. Treatment failure is defined as non-union. Patients may be removed from the study if they are unable to comply with post-operative requirements, or if their injuries are found to be more complex than the study allows for.
  8. If patients are removed from the study prematurely, their treatment will continue as standard of care with their attending physician.

Potential Risks:

A potential risk of this treatment is that a patient will experience a non-union or malunion. This is a normal risk of non-thumb metacarpal fracture.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metacarpal Fracture
Intervention  ICMJE
  • Procedure: Surgical Fixation
    For both scissoring and non-scissoring injuries surgical fixation by either pinning, dorsal plate, or lag screws will be considered. This will be determined by surgeon expertise at the time of surgical fixation. Postoperative, a volar short arm splint and immediate AROM at full range with buddy taping to adjacent digit will be indicated. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.
    Other Name: Fracture Fixation
  • Other: Non-Operative Management
    1. For non-scissoring injuries: Placement of short-arm cast; immediate AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union.
    2. For scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union
    Other Name: Conservative Management
Study Arms  ICMJE
  • Active Comparator: Non-operatively
    1. Adults 18 and older
    2. Native English-speaker
    3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)
    Intervention: Procedure: Surgical Fixation
  • Active Comparator: Surgical
    1. Adults 18 and older
    2. Native English-speaker
    3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries)
    Intervention: Other: Non-Operative Management
Publications *
  • Macdonald BB, Higgins A, Kean S, Smith C, Lalonde DH. Long-term follow-up of unoperated, nonscissoring spiral metacarpal fractures. Plast Surg (Oakv). 2014 Winter;22(4):254-8.
  • Eglseder WA Jr, Juliano PJ, Roure R. Fractures of the fourth metacarpal. J Orthop Trauma. 1997 Aug;11(6):441-5.
  • Al-Qattan MM. Outcome of conservative management of spiral/long oblique fractures of the metacarpal shaft of the fingers using a palmar wrist splint and immediate mobilisation of the fingers. J Hand Surg Eur Vol. 2008 Dec;33(6):723-7. doi: 10.1177/1753193408093559. Epub 2008 Jul 28.
  • Westbrook AP, Davis TR, Armstrong D, Burke FD. The clinical significance of malunion of fractures of the neck and shaft of the little finger metacarpal. J Hand Surg Eur Vol. 2008 Dec;33(6):732-9. doi: 10.1177/1753193408092497. Epub 2008 Oct 20.
  • Kollitz KM, Hammert WC, Vedder NB, Huang JI. Metacarpal fractures: treatment and complications. Hand (N Y). 2014 Mar;9(1):16-23. doi: 10.1007/s11552-013-9562-1. Review.
  • Giddins GE. The non-operative management of hand fractures. J Hand Surg Eur Vol. 2015 Jan;40(1):33-41. doi: 10.1177/1753193414548170. Epub 2014 Sep 12. Review.
  • Khan A, Giddins G. The outcome of conservative treatment of spiral metacarpal fractures and the role of the deep transverse metacarpal ligaments in stabilizing these injuries. J Hand Surg Eur Vol. 2015 Jan;40(1):59-62. doi: 10.1177/1753193414540408. Epub 2014 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 20, 2035
Estimated Primary Completion Date January 20, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults 18 and older
  • Native English-speaker
  • Non-thumb isolated single metacarpal shaft closed fracture

Exclusion Criteria:

  • Pre-existing condition in the involved hand/wrist, hand contracture or deformity, pre-existing stiffness
  • Cognitive dysfunction with inability to follow rehabilitation protocol
  • Subacute/chronic fracture (>4 weeks)
  • Pregnant Participants
  • VA patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacee Clawson 573-884-9017 clawsons@health.missouri.edu
Contact: Lauren Livesay livesayl@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001062
Other Study ID Numbers  ICMJE 2014561
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No The Investigator will maintain all study records according to applicable University regulatory requirement(s). Hard copy records will be retained for at least 7 years after the last clinic follow-up visit at the Missouri Orthopaedic Institute in a locked filing cabinet. Electronic records will be retained for the same amount of time but on secured computers and servers. If the Investigator withdraws from the responsibility of keeping the study records, custody will be transferred to a person willing to accept the responsibility.
Responsible Party Sebastien Lalonde, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sebastian Lalonde, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP