Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.

NCT ID: NCT05015556

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-31

Brief Summary

Nondisplaced distal radial fractures are nowadays treated by plaster cast immobilization. In this study, the investigators challenge this classical standard treatment with a surgical solution: minimal invasive volar plating with pronatus quadratus sparing approach. Potential benefits of this surgical treatment are higher cost effectiveness, economical benefit, earlier recuperation of professional and recreational activities, earlier functional recuperation by faster clinical recovery (range of motion, grip strength) and decreased risk of secondary fracture displacement. Potential drawbacks are surgical risks and complications.

Detailed Description

Randomized controlled trial Number still to be determined by power analysis on economical outcome measurement Similar study number = 90 Randomization by computer.

RZ Tienen, Dr Goorens Level 4 hand surgeon

Inclusion criteria:

• Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
• 18 - 65 years, professional active

Exclusion criteria:

• associated lesions, open fractures, unstable, displaced fractures
• neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist

Treatment

1. Cast treatment: 6 weeks with 1 plaster exchange of after 2 weeks

2. Minimal invasive plating: no cast

Followup 2 weeks, 6 weeks, 3 months, 6 months, 1 year

Primary PROM:

• Cost effectiveness: QALY SF-36
• Direct costs: surgery, hospitalisation, follow-up consultations, imaging, medication, wound care, nurse cost, physiotherapy cost
• Indirect costs: loss of productivity (SF-HLQ)
• Health insurances costs
• Confounding factors

• Independent vs servant
• Insurance?
• Work type?
• Age, sex, dominance
• Work absence, professional recuperation
• Recreational sport resumption

Secondary PROM

• ROM (F/E/RD/UD/P/S)
• Grip strength (Jamar)
• Pain (VAS)
• DASH scare, PRWE score
• Satisfaction (VAS), would you do it again?
• RX ulna variance, radial tilt
• complications

Conditions

Radius Fracture Distal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Casting

Casting of the distal radius for 6 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Minimal invasive volar plating

Muscle sparing osteosynthesis, no casting postoperatively

Group Type: ACTIVE_COMPARATOR

Minimal invasive volar plating

Intervention Type: PROCEDURE

Muscle sparing osteosynthesis, no casting postoperatively

Interventions

Minimal invasive volar plating

Muscle sparing osteosynthesis, no casting postoperatively

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
• 18 - 65 years, professional active

Exclusion Criteria

• associated lesions, open fractures, unstable, displaced fractures
• neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Goorens Chul Ki

OTHER

Sponsor Role: lead

Responsible Party

Goorens Chul Ki

M.D., Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lieselot Brepoels, MD

Role: STUDY_DIRECTOR

RZ Tienen

Locations

Department of orthopaedics RZ Tienen

Tienen, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

chul ki goorens, MD

Role: CONTACT

cgoorens@msn.com

0032478907124

Facility Contacts

chul ki goorens, md

Role: primary

Other Identifiers

109

Identifier Type: -

Identifier Source: org_study_id