Sexual Dysfunction Following Upper Extremity Trauma

NCT04764578 | Withdrawn

• 1 other identifier: 210352
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothesis

1. 1.The prevalence of sexual dysfunction after upper extremity function in adults (\>18yo) is higher than the general population in the early post-operative period (3mo) and at 1 year post-operatively.
2. 2.Null: Adult patients (\<18 yo) with isolated upper extremity trauma do not experience sexual dysfunction more than the general population.
3. 3.Are there patient or injury factors that can predict sexual dysfunction?
4. 4.Do certain fractures cause more sexual dysfunction than others?
5. 5.Can we accurately predict which patients may experience sexual dysfunction post-injury?

Conditions

Sexual Dysfunction; Upper Extremity Trauma

Outcome Measures

Primary Outcomes (2)

• Disabilities of the Arm, Shoulder and Hand (Item 21 Sexual Dysfunction) Score

  The DASH item response ranges from 1 (no difficulty) to 5 (unable). 21 Item Sexual Dysfunction from the Disabilities of Arm, Shoulder and Hand (DASH)

  Change between baseline, 3-month, 6-month, and 12-month visits.

• Arizona Sexual Experience Scale (ASEX) Score

  The Arizona Sexual Experience Scale (ASEX) is a 5 item Likert-like scale with response ranges from 1 (extremely easily) to 6 (never).

  Change between baseline, 3-month, 6-month, and 12-month visits.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be identified when they present to Vanderbilt University Medical Center or Vanderbilt Department of Orthopaedic Clinics for follow up for their isolated upper extremity trauma.

You may qualify if:

• All adult patients \> 18 years old with an isolated upper extremity injury treated operatively or non-operatively at Vanderbilt University Medical Center
• Isolated upper extremity is defined as:
• Fractures, stratified by level
• Hand (phalanx, metacarpal), wrist (carpal, distal radius), forearm (radial shaft, ulnar shaft, both bone), elbow (distal humerus, proximal ulna, radial head), arm (humeral shaft), shoulder (proximal humerus, scapula, clavicle)
• Soft tissue trauma involving ligament or muscle injury requiring repair or soft tissue defect requiring flap coverage
• Nerve injury, stratified by level
• Peripheral nerve injury vs plexus injury
• Vascular injury
• Amputation
• Combined injury

You may not qualify if:

• Age \< 18 at time of injury
• Traumatic brain injury
• Other concomitant orthopaedic injury to the lower extremities
• Other trauma requiring hospital admission (abdominopelvic, thoracic, head or spine trauma)
• Patients with bilateral upper extremity injuries

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2022
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11