Minimal Invasive Volar Plating Versus Cast Immobilization... | NCT05015556

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

NCT05015556

Sponsor

Goorens Chul Ki

Status

Unknown status

Last Update Posted

Oct 5, 2022Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Radius Fracture Distal

Interventions

Minimal invasive volar plating

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 3, 2021

First Submission Date that Met QC Criteria

Aug 14, 2021

First Posted Date

Aug 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2022

Last Update Posted Date

Oct 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Goorens Chul Ki, M.D., Principal Investigator, Regionaal Ziekenhuis Heilig Hart TienenSponsor-Investigator

Lead Sponsor

Goorens Chul KiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Casting	No Intervention	Casting of the distal radius for 6 weeks
Minimal invasive volar plating	Active Comparator	Muscle sparing osteosynthesis, no casting postoperatively	Procedure: Minimal invasive volar plating

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minimal invasive volar plating	Procedure	Muscle sparing osteosynthesis, no casting postoperatively	Minimal invasive volar plating

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Costs	Direct, indirect, health insurances	1 year

Secondary Outcomes

Measure	Description	Time Frame
Wrist ROM	Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)	1 year
Grip Strength	Using the Jamar grip dynamometer

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
chul ki goorens, MD	Contact	0032478907124		cgoorens@msn.com

Overall Officials

Name	Affiliation	Role
Lieselot Brepoels, MD	RZ Tienen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of orthopaedics RZ Tienen	Recruiting	Tienen		3300	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

clinical and economical data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

Blinding of results by computer of the outcome results. Blinding of the patients or the care provider is not possible due to the obvious differences.

Who Masked

Outcomes Assessor