Metacarpal FractureNCT04001062
Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures
A study testing Surgical Fixation and Non-Operative Management in people with Metacarpal Fracture, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- Surgical Fixation and Non-Operative Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 and older
- Native English-speaker
- Non-thumb isolated single metacarpal shaft closed fracture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures, A Randomized Controlled Trial
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.
Read the 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.
- 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:
- 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.
- Pre-operatively, the patient will have the following standard of care procedures:
- Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS),
- Radiographic measurement of metacarpal shortening
- Range of Motion Measurements
- Malrotation (scissoring/gapping) measurement
- Pre-operatively, the patient will have the following procedures as research only:
- Disabilities of the Arm, Shoulder and Hand survey (DASH)
- Surgical Treatment vs. Non-Surgical Treatment Groups
- For non-operatively addressed scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range active range of motion (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.
- For non-operatively addressed non-scissoring injuries: Placement of short-arm cast; immediate active range of motion (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.
- 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 (AROM) 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.
- 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:
- Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS)
- Radiographic measurement of metacarpal shortening
- Range of Motion Measurements
- Malrotation (scissoring/gapping) measurement
- Grip Strength (at 6 week, 3 month, and 6 month follow-ups only)
- Notation of timing of clinical union based upon the lack of tenderness on palpation or stress
- Notation of the timing of radiographic union, based on bony bridging across the fracture site
- Post-operatively, the patient will have the following research only procedures at the 2 week, 6 week, 3 month and 6 month time points:
- Disabilities of the Arm, Shoulder and Hand survey (DASH)
- 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.
- 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.
- Conditions
- Metacarpal Fracture
- Being tested
- Surgical Fixation, Non-Operative Management
- Keywords
- Metacarpal Shaft Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical FixationProcedure or surgery
Also called Fracture 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.
Non-Operative ManagementOther
Also called Conservative Management
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Non-operatively | Active comparator | 1. Adults 18 and older
2. Native English-speaker
3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries) Receives: Procedure: Surgical Fixation |
| Surgical | Active comparator | 1. Adults 18 and older
2. Native English-speaker
3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries) Receives: Other: Non-Operative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Extension lag
Measured with a goniometer and expressed in degrees (°)
Measured: 6 months
Finger Range of Motion
Measured with a goniometer and expressed in degrees (°)
Measured: 6 months
Time to union
Time to achieve clinical and radiologic formation of a stable callus, documented in days
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start12 Jun 2019
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Why it stopped: PI left institution prior to results being available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metacarpal FractureStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Bridgeman, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001062
- Sponsor's protocol ID
- 2014561
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2019
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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. doi: 10.4172/plastic-surgery.1000888.
PubMed 25535464Eglseder WA Jr, Juliano PJ, Roure R. Fractures of the fourth metacarpal. J Orthop Trauma. 1997 Aug;11(6):441-5. doi: 10.1097/00005131-199708000-00014.
PubMed 9314153Al-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.
PubMed 18662959Westbrook 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.
PubMed 18936129Kollitz 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.
PubMed 24570632Giddins 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.
PubMed 25217094Khan 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.
PubMed 24963083
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative vs Surgical Treatment of Isolated Non-Thumb Metacarpal Shaft Fractures, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04001062
- Acronym / sponsor ID
- 2014561
- Conditions
- Metacarpal Fracture
- Keywords
- Metacarpal Shaft Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution prior to results being available.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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:
- 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.
- Pre-operatively, the patient will have the following standard of care procedures:
- Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS),
- Radiographic measurement of metacarpal shortening
- Range of Motion Measurements
- Malrotation (scissoring/gapping) measurement
- Pre-operatively, the patient will have the following procedures as research only:
- Disabilities of the Arm, Shoulder and Hand survey (DASH)
- Surgical Treatment vs. Non-Surgical Treatment Groups
- For non-operatively addressed scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range active range of motion (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.
- For non-operatively addressed non-scissoring injuries: Placement of short-arm cast; immediate active range of motion (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.
- 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 (AROM) 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.
- 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:
- Patient reported outcomes, including the PROMIS forms and Visual Analog Scale (VAS)
- Radiographic measurement of metacarpal shortening
- Range of Motion Measurements
- Malrotation (scissoring/gapping) measurement
- Grip Strength (at 6 week, 3 month, and 6 month follow-ups only)
- Notation of timing of clinical union based upon the lack of tenderness on palpation or stress
- Notation of the timing of radiographic union, based on bony bridging across the fracture site
- Post-operatively, the patient will have the following research only procedures at the 2 week, 6 week, 3 month and 6 month time points:
- Disabilities of the Arm, Shoulder and Hand survey (DASH)
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-operatively | Active comparator | Procedure: Surgical Fixation1. Adults 18 and older 2. Native English-speaker 3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries) |
| Surgical | Active comparator | Other: Non-Operative Management1. Adults 18 and older 2. Native English-speaker 3. Non-thumb isolated single metacarpal shaft closed fracture (both scissoring and non-scissoring injuries) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 and older
- Native English-speaker
- Non-thumb isolated single metacarpal shaft closed fracture
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical FixationAlso: Fracture FixationFor 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. | Procedure or surgery | Non-operatively |
| Non-Operative ManagementAlso: Conservative Management1. 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 | Surgical |
Primary outcome
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 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).
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).
Results and safety
The study was stopped early (reason given: PI left institution prior to results being available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 25535464Macdonald 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. doi: 10.4172/plastic-surgery.1000888.
- Background: PubMed 9314153Eglseder WA Jr, Juliano PJ, Roure R. Fractures of the fourth metacarpal. J Orthop Trauma. 1997 Aug;11(6):441-5. doi: 10.1097/00005131-199708000-00014.
- Background: PubMed 18662959Al-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.
- Background: PubMed 18936129Westbrook 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.
- Background: PubMed 24570632Kollitz 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.
- Results publication: PubMed 25217094Giddins 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.
- Results publication: PubMed 24963083Khan 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Bridgeman, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Fixation and Non-Operative Management in people with Metacarpal Fracture, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution prior to results being available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vas Pain Score (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001062, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.