Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03891966
Enrollment
122
Registered
2019-03-27
Start date
2018-11-08
Completion date
2023-08-01
Last updated
2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremity Injury

Keywords

Upper Extremity Fracture

Brief summary

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.

Interventions

PROCEDURERigid Splint

50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.

PROCEDURESoft Dressing

50 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a soft dressing post-operatively.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent change in Visual Analog Scale (VAS)14 DaysBest state you can imagine is marked 100and the worst state you can imagine is marked 0 on a line
Percent Change in Euro Quality of Life (EQ-5D)14 DaysThe descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026