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Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Extremity Injury

Treatments

Procedure: Rigid Splint
Procedure: Soft Dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT03891966
18-01505

Details and patient eligibility

About

The goal of this study is to determine if applying a rigid splint helps to reduce pain following operative fixation of upper extremity fractures. Orthopedic trauma surgeons currently vary in their application of rigid post-operative splints versus soft dressings after certain surgical procedures based on personal preference. In this study, 100 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint or soft dressing post-operatively. Their pain, medication usage and function will be tracked over the 2- week postoperative period to see if splinting has any impact on outcomes.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Willing and able to participate in study and complete consent
  • Will undergo operative fixation of an isolated both bone forearm, radial head, olecranon, distal humerus fracture, or humeral shaft fracture.

Exclusion criteria

  • Pregnant women
  • Patients with concomitant TBI or MR
  • Polytrauma patients
  • Pathologic Fractures
  • Patients undergoing treatment for malignancy
  • NYU SoM Students, Residents, Faculty
  • Prisoners
  • IV drug users or patients on chronic narcotics
  • Gun shot wound victims

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

122 participants in 2 patient groups

Splint
Active Comparator group
Treatment:
Procedure: Rigid Splint
Soft Dressing
Active Comparator group
Treatment:
Procedure: Soft Dressing

Trial contacts and locations

1

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Central trial contact

Philipp Leucht, MD

Data sourced from clinicaltrials.gov

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