Metacarpal Fracture Clinical Trial
Official title:
Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures, A Randomized Controlled Trial
NCT number | NCT04001062 |
Other study ID # | 2014561 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 12, 2019 |
Est. completion date | April 15, 2022 |
Verified date | June 2023 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | April 15, 2022 |
Est. primary completion date | April 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vas Pain Score | 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." | 6 months | |
Primary | PROMIS score | 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 questionnarie 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). | 6 months | |
Primary | Disabilities of the Arm, Shoulder and Hand (DASH) | 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. | 6 months | |
Primary | Grip Strength | 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 | 6 months | |
Primary | Extension lag | Measured with a goniometer and expressed in degrees (°) | 6 months | |
Primary | Finger Range of Motion | Measured with a goniometer and expressed in degrees (°) | 6 months | |
Primary | Time to union | Time to achieve clinical and radiologic formation of a stable callus, documented in days | 6 months | |
Primary | Adverse events | 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). |
6 months |
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