Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869331
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2023-05-11
Brief Title:
Midterm Min 3yr Follow-up of Patients With Single SpiralOblique Finger Metacarpal Fracture
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Midterm Min 3yr Follow-up of Patients With Single SpiralOblique Finger Metacarpal Fracture Following Early Mobilization Nonoperative Treatment or Operative Treatment With Screw Fixation - a Noninferiority Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spiral metacarpal fractures metacarpal II-V can be treated conservatively or with operation With minimal displacement this fracture is usually treated with immobilisation or early mobilisation With appreciable displacement especially any malrotation the patient usually is treated with an operation This usually includes an open reduction of the fracture and fixation with plates and screws or just screws
The hypothesis that nonoperative treatment using early mobilization without splintage will result in similar outcomes to operative treatment was previously tested by this research group Peyronson et al JBJS American 2023 Over a 1-year follow-up the primary outcome of grip strength was found to be noninferior
This trial will extend the follow-up period and re-evaluate the patients included in the original cohort to identify any difference over a 3-6 year follow up
The hypothesis that nonoperative treatment using early mobilization without splintage will result in similar outcomes to operative treatment was previously tested by this research group Peyronson et al JBJS American 2023 Over a 1-year follow-up the primary outcome of grip strength was found to be noninferior
This trial will extend the follow-up period and re-evaluate the patients included in the original cohort to identify any difference over a 3-6 year follow up
Detailed Description:
The original trial was a noninferiority randomized controlled trial evaluating 42 patients Randomization was performed 11 to either nonoperative treatment with mobilization initiated immediately following recruitment or operative treatment using ORIF with cortical screws or locking compression plate LCP and screw fixation
The non-inferiority margin NIM was defined as -15 grip strength of the injured hand relative to the contralateral hand The same NIM will be used for this trial
Because subtle biomechanical changes mainly metacarpal bone shortening could theoretically cause problems not evident at 1-year follow-up such as joint degeneration from changes in load distribution the investigators plan to re-evaluate the patients for a longer-term follow-up
Only patients included in the original trial will be eligible for inclusion in this extended follow-up Participation will be offered via mail invitation and participants will be offered financial compensation in the form of a single payment of 500SEK
Data collection will be performed in a single outpatient hospital visit where patient history subjective outcome data and bilateral plain radiography of the hands will be obtained
The non-inferiority margin NIM was defined as -15 grip strength of the injured hand relative to the contralateral hand The same NIM will be used for this trial
Because subtle biomechanical changes mainly metacarpal bone shortening could theoretically cause problems not evident at 1-year follow-up such as joint degeneration from changes in load distribution the investigators plan to re-evaluate the patients for a longer-term follow-up
Only patients included in the original trial will be eligible for inclusion in this extended follow-up Participation will be offered via mail invitation and participants will be offered financial compensation in the form of a single payment of 500SEK
Data collection will be performed in a single outpatient hospital visit where patient history subjective outcome data and bilateral plain radiography of the hands will be obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None