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

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ClinicalTrials.gov Identifier: NCT05015556
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Goorens Chul Ki, Regionaal Ziekenhuis Heilig Hart Tienen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Radius Fracture Distal Procedure: Minimal invasive volar plating Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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.
Primary Purpose: Treatment
Official Title: Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Casting
Casting of the distal radius for 6 weeks
Active Comparator: Minimal invasive volar plating
Muscle sparing osteosynthesis, no casting postoperatively
 Procedure: Minimal invasive volar plating
Muscle sparing osteosynthesis, no casting postoperatively


Outcome Measures
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Primary Outcome Measures :
  1. QALY [ Time Frame: 1 year ]
    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.)

  2. Costs [ Time Frame: 1 year ]
    Direct, indirect, health insurances


Secondary Outcome Measures :
  1. Wrist ROM [ Time Frame: 1 year ]
    Range of motion (flexion, extension, radial deviation, ulnar deviation, pronation, supination)

  2. Grip Strength [ Time Frame: 1 year ]
    Using the Jamar grip dynamometer

  3. VAS [ Time Frame: 1 year ]
    Pain using the VAS (0-10)

  4. DASH [ Time Frame: 1 year ]
    Disabilities of the arm, shoulder and hand (0-100, lower score means better outcome)

  5. PRWE [ Time Frame: 1 year ]
    Patient rated wrist evaluation (0-100, lower score, means better outcome)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015556


Contacts
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Contact: chul ki goorens, MD 0032478907124 cgoorens@msn.com

Locations
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Belgium
Department of orthopaedics RZ Tienen Recruiting
Tienen, Belgium, 3300
Contact: chul ki goorens, md         
Principal Investigator: chul ki goorens, md         
Sub-Investigator: niels debaenst, md         
Sponsors and Collaborators
Goorens Chul Ki
Investigators
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Study Director: Lieselot Brepoels, MD RZ Tienen
More Information
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Responsible Party: Goorens Chul Ki, M.D., Principal Investigator, Regionaal Ziekenhuis Heilig Hart Tienen
ClinicalTrials.gov Identifier: NCT05015556    
Other Study ID Numbers: 109
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: clinical and economical data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Goorens Chul Ki, Regionaal Ziekenhuis Heilig Hart Tienen:
Minimal invasive
Osteosynthesis
Conservative treatment
Cost effectiveness
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries