Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06019585

Immobilization With Compression Bandage vs Forearm Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study

Led by Hospital Costa del Sol · Updated on 2023-08-31

120

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing the functional and radiological outcomes of two different immobilization methods in patients with distal radius fractures treated with internal fixation using a volar locking plate. The study also aims to evaluate possible complications following these treatments. The study focuses on patients aged 18 to 75 years with specific types of distal radius fractures classified under the AO system. Participants are divided into two groups: one group receives immobilization with a forearm plaster splint for three weeks after surgery, while the other group receives immobilization with a compressive bandage for the same duration. Both groups undergo internal fixation with a volar locking plate prior to immobilization. The hypothesis is that the compression bandage may offer better short-term results, while no significant difference is expected after three to six months. During the study, participants' pain levels will be assessed using the Visual Analogue Scale, and wrist function will be measured with the Patient Rated Wrist Evaluation Scale over one year. Range of motion in various directions will also be evaluated, along with postoperative complications and the time of fracture healing seen on radiographs within 12 weeks. Additional function scales, number of physiotherapy sessions, and fracture stability criteria will be recorded. The total participation period includes follow-up for up to one year to monitor recovery and outcomes.

CONDITIONS

Brief Title

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with type A, B, C fractures of AO classification of distal radius fractures
  • Patients aged between 18 and 75 years
  • Patients operated on in the first 3 weeks after the trauma
  • Patients independent for basic activities of daily living
Not Eligible

You will not qualify if you...

  • Patients with open fractures
  • Patients with mental disorders such as dementia or alcoholism
  • Patients dependent for basic activities of daily living
  • Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO)
  • Patients with previous diseases or anatomical alterations in the injured wrist such as previous fractures or rheumatoid arthritis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo open reduction and internal fixation of distal radius fractures with a volar locking plate.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants are immobilized using either a forearm splint or a compression bandage for 3 weeks following surgery.

1 to 2 visits depending on immobilization method

Post-operative Follow-up

Duration - Up to 1 year

Participants are followed up to assess pain, function, range of motion, fracture healing, and complications for up to 1 year after treatment.

Regular follow-up visits over 1 year

Trial Site Locations

Total: 2 locations

1

Hospital Reina Sofía

Córdoba, Spain, 14004

Actively Recruiting

2

Hospital Costa del Sol

Málaga, Spain, 29603

Actively Recruiting

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Research Team

J

Jose Ignacio Miró Jiménez, MD

A

Alberto Izquierdo Fernández, Phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study.

Stefan Quadlbauer, Christoph Pezzei, Josef Jurkowitsch...

https://pubmed.ncbi.nlm.nih.gov/28428911

Short Term Outcomes Following Open Reduction Internal Fixation Surgery for a Distal Radius Fracture: 2 Week Versus 4 Week Immobilization. A Retrospective Analysis.

Angela Toemen, Shirley Collocott, Wolfgang Heiss-Dunlop

https://pubmed.ncbi.nlm.nih.gov/35186419

American Academy of Orthopaedic Surgeons clinical practice guideline on: the treatment of distal radius fractures.

David M Lichtman, Randipsingh R Bindra, Martin I Boyer...

https://pubmed.ncbi.nlm.nih.gov/21508285

Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review.

Kristin Valdes, Nancy Naughton, Susan Michlovitz

https://pubmed.ncbi.nlm.nih.gov/24508093

A retrospective cohort investigation of active range of motion within one week of open reduction and internal fixation of distal radius fractures.

Susan Driessens, Trudie Diserens-Chew, Christopher Burton...

https://pubmed.ncbi.nlm.nih.gov/23770202

Wrist mobilization following volar plate fixation of fractures of the distal part of the radius.

Santiago A Lozano-Calderón, Sebastiaan Souer, Chaitanya Mudgal...

https://pubmed.ncbi.nlm.nih.gov/18519324