Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture

Metacarpal Fracture Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05869331
• Other study ID #: 276742
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 29, 2023
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Metacarpal Fracture

Intervention

Procedure:
• Early mobilization
Patients randomized to nonoperative treatment have already received treatment using early mobilization in the original trial, and all fractures have been confirmed healed. Mobilization consisted of 5 repetitions of full finger extension followed by maximum finger flexion, and 5 such sets of 5 were required per day for the first 6 weeks. Buddy taping or resting splint was offered if the patient experienced difficulty, and mobilization was performed by all patients in this treatment arm.
• Operative treatment
Patients randomized to operative treatment have already received treatment using open reduction and internal fixation (ORIF) with cortical screws in the original trial, and all fractures have been confirmed healed. Surgery was performed under general anaesthesia through a dorsal incision centered over the fractured metacarpal. Reduction was performed under visual inspection and fixation performed using 2 or more cortical screws (Synthes Compact Hand 2.0) as first option. At the surgeons preference fixation using plate and screw fixation was also allowed. Postoperatively patients were put in a plaster cast for two weeks and then hand therapy was initiated.

Locations

Country	Name	City	State
Sweden	Falun Regional Hospital	Falun
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength	Grip strength is measured in both hands using a JAMAR dynamometer set to 2nd position with the patient sitting down, arm resting in 90 degree elbow flexion and neutral forearm rotation. Three measurements are taken in each arm and the mean value calculated. The strength of the injured hand is expressed as a percentage value relative to the strength of the contralateral (uninjured) hand.	3-6 years
Secondary	DASH score	Disability of Arm, Shoulder and Hand questionnaire score, a patient-reported outcome measure. Scored 1-100, 1 representing best possible value.	3-6 years
Secondary	Metacarpal shortening	Shortening of the metacarpal bone measured on plain radiographs comparing the length of the injured bone to the contralateral corresponding bone and calculating the difference in millimeters.	3-6 years
Secondary	Rotation	Presence of any rotation deformity on clinical examination	3-6 years
Secondary	Subjective pain	Pain graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value	3-6 years
Secondary	Subjective cosmetic result	Cosmetic result graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value	3-6 years
Secondary	Subjective overall result	Overall result of treatment outcome graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value	3-6 years
Secondary	Time off work	The time off work measured in days, or time until return to normal function (in retired patients or patients attending education)	3-6 years
Secondary	Range of motion	Range of motion of the affected finger ray presented as total active motion (TAM)	3-6 years