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

NCT ID: NCT03891966

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Extremity Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Splint

Group Type ACTIVE_COMPARATOR

Rigid Splint

Intervention Type PROCEDURE

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

Soft Dressing

Group Type ACTIVE_COMPARATOR

Soft Dressing

Intervention Type PROCEDURE

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.

Interventions

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Rigid Splint

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

Intervention Type PROCEDURE

Soft 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp Leucht, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

References

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Sgaglione MW, Solasz SJ, Leucht P, Egol KA. Is Postoperative Splinting Advantageous After Upper Extremity Fracture Surgery? Results From the Arm Splint Pain Improvement Research Experiment. J Orthop Trauma. 2024 Mar 1;38(3):e92-e97. doi: 10.1097/BOT.0000000000002742.

Reference Type DERIVED
PMID: 38117579 (View on PubMed)

Other Identifiers

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18-01505

Identifier Type: -

Identifier Source: org_study_id

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