Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05015556
Other study ID # 109
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03311633 - Complications in Distal Radius Fracture N/A
Recruiting NCT05974254 - Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation N/A
Recruiting NCT04549441 - Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery
Terminated NCT05655130 - Distal Radius Steroid Phase 1
Not yet recruiting NCT05580848 - Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures N/A
Withdrawn NCT04359017 - Systemic Absorption of Lidocaine After Hematoma Block Phase 4
Withdrawn NCT04135768 - A Study Examining The Effect Of Wrist Joint Haematoma Washout As An Adjunct Procedure To Plating Of The Distal Radius In Fractures Of The Distal Radius Involving The Wrist Joint N/A
Completed NCT03716661 - Operative vs. Conservative Treatment of Distal Radius Fractures N/A
Recruiting NCT06046404 - Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department N/A
Completed NCT03186963 - Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures N/A
Not yet recruiting NCT05318729 - Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures N/A
Completed NCT03468023 - Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial N/A
Completed NCT05346926 - Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures N/A
Recruiting NCT05008029 - Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius N/A
Completed NCT01497080 - Distal Radius Fracture Prospective Database 50-80 Years Old N/A
Not yet recruiting NCT05631314 - Lets Agree to Disagree on Operative vs Nonoperative Treatment for Distal Radius Fractures in the Elderly (LADON Radius)
Completed NCT05421000 - WALANT in Distal Radius Fracture Osteosynthesis N/A
Recruiting NCT05371938 - Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up N/A
Not yet recruiting NCT03359278 - Effects of Ulnar Styloid and Sigmoid Notch Fractures on Postoperative Wrist Function of Distal Radius Fracture Patients N/A