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

Radius Fracture Distal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015556
• Other study ID #: 109
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Regionaal Ziekenhuis Heilig Hart Tienen
• Contact: chul ki goorens, MD
• Phone: 0032478907124
• Email: cgoorens[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

Procedure:
• Minimal invasive volar plating
Muscle sparing osteosynthesis, no casting postoperatively

Locations

Country	Name	City	State
Belgium	Department of orthopaedics RZ Tienen	Tienen

Sponsors (1)

Lead Sponsor	Collaborator
Goorens Chul Ki

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QALY	Using the Short Form 36 (SF-36) assessment - cost effectiveness (The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.)	1 year
Primary	Costs	Direct, indirect, health insurances	1 year
Secondary	Wrist ROM	Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)	1 year
Secondary	Grip Strength	Using the Jamar grip dynamometer	1 year
Secondary	VAS	Pain using the VAS (0-10)	1 year
Secondary	DASH	Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)	1 year
Secondary	PRWE	Patient rated wrist evaluation (0-100, lower score, means better outcome)	1 year