Clinical trial NCT05869331: Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture
Official title: Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture Following Early Mobilization Nonoperative Treatment or Operative Treatment With Screw Fixation - a Noninferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metacarpal Fracture
Keywords: Metacarpal fracture
Spiral fracture
Early mobilization
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The original trial was a noninferiority randomized controlled trial evaluating 42 patients. Randomization was performed 1:1 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.

Eligibility criteria: Inclusion Criteria:

Previous inclusion in the original study population, i.e.:

* Diaphyseal, single spiral, and oblique fractures of the index to little finger metacarpals
* Fracture line length at least twice the diameter of the bone at the level of the fracture
* At least 2-mm displacement and/or shortening of the fracture or malrotation
* Normal hand function before the injury
* Fracture \<10 days old

Exclusion Criteria:

* Multiple metacarpal fractures
* Open fractures
* Inability to follow instructions
* Fracture line length less than twice the diameter of the bone at the level of the fracture
* Abnormal hand function before the injury
* Previous ipsilateral hand fractures
* Fracture ≥10 days old at possible randomization

Primary outcomes:
measure: Grip strength
timeFrame: 3-6 years
Secondary outcomes:
measure: DASH score
timeFrame: 3-6 years
measure: Metacarpal shortening
timeFrame: 3-6 years
measure: Rotation
timeFrame: 3-6 years
measure: Subjective pain
timeFrame: 3-6 years
measure: Subjective cosmetic result
timeFrame: 3-6 years
measure: Subjective overall result
timeFrame: 3-6 years
measure: Time off work
timeFrame: 3-6 years
measure: Range of motion
timeFrame: 3-6 years
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falun Regional Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Region Dalarna
name: Björn Äng, Professor
role: STUDY_CHAIR
References:
citation: Peyronson F, Ostwald CS, Hailer NP, Giddins G, Vedung T, Muder D. Nonoperative Versus Operative Treatment for Displaced Finger Metacarpal Shaft Fractures: A Prospective, Noninferiority, Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Jan 18;105(2):98-106. doi: 10.2106/JBJS.22.00573. Epub 2022 Nov 10.