| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metacarpal Fracture | Procedure: Surgical Fixation Other: Non-Operative Management | Not Applicable |
Show detailed description
| 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 |
| Arm | Intervention/treatment |
|---|---|
Active Comparator: Non-operatively
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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
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Active Comparator: Surgical
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Other: Non-Operative Management
Other Name: Conservative Management
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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).
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Stacee Clawson | 573-884-9017 | clawsons@health.missouri.edu | |
| Contact: Lauren Livesay | livesayl@health.missouri.edu |
| United States, Missouri | |
| University of Missouri | Recruiting |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: | Sebastian Lalonde, MD | University of Missouri-Columbia |
| Tracking Information | |||||||||
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| 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 |
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| 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:
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. |
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| 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 |
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| Condition ICMJE | Metacarpal Fracture | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04001062 | ||||||||
| Other Study ID Numbers ICMJE | 2014561 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Sebastien Lalonde, University of Missouri-Columbia | ||||||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Missouri-Columbia | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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