Does Early Elbow Motion Improve Patient Outcomes After Surgically Treated Elbow Fractures?

NCT05980312 | Completed

• 1 other identifier: 19-196
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and efficacy, defined as improved range of motion and functional outcome scores, of early elbow motion in the early (immediately post-op) and late postoperative periods (2 week post-op).

Conditions

Elbow Fracture; Range of Motion; Immobilization

Outcome Measures

Primary Outcomes (3)

• ASES-E Scores

  A standardized elbow evaluation was developed by the Research Committee of the American Shoulder and Elbow Surgeons 1 (ASES). This score allows the evaluation of elbow function independently from the underlying diagnosis.

  Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

• HSS Elbow Score

  The Hospital for Special Surgery (HSS) scoring system 31 consists of eight domains described as pain, function, sagittal range, muscle strength, flexion contracture, extension contracture, pronation, and supination.

  Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

• Range of Motion

  Preoperative and postoperatively as 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

Study Arms (2)

Immobilized

ACTIVE COMPARATOR

Patients in the control group will be immobilized for 2 weeks and resume unrestricted motion once the splint is taken off.

Other: Splint Immobilization

Early Range of Motion

EXPERIMENTAL

Patients in the experimental group will start early motion immediately after surgery.

Other: Early Motion

Interventions

Splint Immobilization OTHER

Patients will be randomized to receive a splint following their surgical procedure.

Immobilized

Early Motion OTHER

Patients will be randomized to receive no splint following their surgical procedure.

Early Range of Motion

Eligibility Criteria

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

You may qualify if:

• Subjects must have undergone operative treatment for an elbow fracture
• Operative indications for elbow fractures include: Type 13 humerus fractures including all subtypes, Type 2r1 radius fractures including all subtypes, Type 2u1 ulna fractures including all subtypes.
• Individuals over the age of 18 years old.

You may not qualify if:

• Any patient who had not undergone operative treatment of an elbow fracture will be excluded.
• Patients who were not treated surgically by an orthopaedic surgeon or were treated outside of the study frame will be excluded.
• Individuals under the age of 18.
• Pregnant women.
• Patients admitted to the intensive care unit (ICU).
• Patients with a history of trauma or injury to the affected elbow will be excluded.
• Patients with extensive soft tissue injury of the elbow, which is defined as any injury that requires graft coverage, will be excluded.
• Non-English speaking patients will be excluded.
• Decisional-impaired patients will be excluded (as no substitute consent is requested).

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Elbow Fractures

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Prospective, randomized clinical trial

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: December 27, 2019
• Primary Completion: January 1, 2023
• Study Completion: April 20, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)