Complications in Distal Radius Fracture

NCT03311633 | Completed DMC

• 1 other identifier: OR17-00011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND. Distal radius fractures (FRD) are up to 17% of all diagnosed fractures and are the most commonly treated fractures in adult orthopedic patients. The management could be either conservative or surgical, depending on AO bone fracture classification. The principles of good treatment involves an anatomical reduction with a proper immobilization that keep the reduction. OBJECTIVE. Determine if percutaneous pinning for six weeks versus three has major complications in distal radius fractures.

Conditions

Radius Fracture Distal

Keywords

Radius Fracture Distal; Radius Fracture Distal Therapy; Fracture fixation; Closed Fracture Reduction

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  It´s a numeric scale, when 0 value is equal to no pain; and 10 is equal to a maximum pain

  14 week

Secondary Outcomes (4)

• Patient Rated Wrist Evaluation (PRWE)

  14 weeks

• Wrist mobility

  14 weeks

• Grip strength

  14 weeks

• Skin condition

  6 weeks

Study Arms (2)

3 week percutaneous pinning group

EXPERIMENTAL

Percutaneous pinning time will be for three weeks and short cast immobilization for six weeks.

Procedure: Percutaneous pinning time

6 week percutaneous pinning group

ACTIVE COMPARATOR

Percutaneous pinning time will be for six weeks and also short cast immobilization.

Procedure: Percutaneous pinning time

Interventions

Percutaneous pinning time PROCEDURE

Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.

3 week percutaneous pinning group; 6 week percutaneous pinning group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 18 ages
• any gender
• distal radius fracture type A or B of AO classification managed with closed reduction and percutaneous pinning
• and Informed Consent signature

You may not qualify if:

• associated ipsilateral fractures in the upper extremity
• fractures attended and fixed at another institution
• support external fixation
• previous skin conditions (infection, ulcers)
• limitation of wrist mobility prior to injury

Sponsors & Collaborators

• Carlos A Acosta-Olivo: lead

Study Sites (2)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64480, Mexico

Location

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 66460, Mexico

Location

Related Publications (6)

• Tahririan MA, Javdan M, Motififard M. Results of pronator quadratus repair in distal radius fractures to prevent tendon ruptures. Indian J Orthop. 2014 Jul;48(4):399-403. doi: 10.4103/0019-5413.136275.

  PMID: 25143645 RESULT

• Niver GE, Ilyas AM. Carpal tunnel syndrome after distal radius fracture. Orthop Clin North Am. 2012 Oct;43(4):521-7. doi: 10.1016/j.ocl.2012.07.021. Epub 2012 Sep 4.

  PMID: 23026468 RESULT

• Dhainaut A, Daibes K, Odinsson A, Hoff M, Syversen U, Haugeberg G. Exploring the relationship between bone density and severity of distal radius fragility fracture in women. J Orthop Surg Res. 2014 Jul 17;9:57. doi: 10.1186/s13018-014-0057-8.

  PMID: 25030810 RESULT

• Henn CM, Wolfe SW. Distal radius fractures in athletes: approaches and treatment considerations. Sports Med Arthrosc Rev. 2014 Mar;22(1):29-38. doi: 10.1097/JSA.0000000000000003.

  PMID: 24651288 RESULT

• Turner RG, Faber KJ, Athwal GS. Complications of distal radius fractures. Orthop Clin North Am. 2007 Apr;38(2):217-28, vi. doi: 10.1016/j.ocl.2007.02.002.

  PMID: 17560404 RESULT

• Davis DI, Baratz M. Soft tissue complications of distal radius fractures. Hand Clin. 2010 May;26(2):229-35. doi: 10.1016/j.hcl.2009.11.002.

  PMID: 20494749 RESULT

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Carlos Acosta-Olivo, PhD

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three week percutaneous pinning group versus Six week percutaneous pinning group

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: September 29, 2017
• Primary Completion: April 20, 2024
• Study Completion: April 23, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ME (2)