Clinical trial NCT04764578: Sexual Dysfunction Following Upper Extremity Trauma
Official title: Sexual Dysfunction Following Upper Extremity Trauma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sexual Dysfunction
Upper Extremity Trauma
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: Hypothesis

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. Null: Adult patients (\<18 yo) with isolated upper extremity trauma do not experience sexual dysfunction more than the general population.

Primary Study Question

a) What is the prevalence of sexual dysfunction after upper extremity trauma (fracture, soft tissue disruption, neurovascular injury, and completion amputation) in adult patients?

Secondary Study Questions

1. Are there patient or injury factors that can predict sexual dysfunction?
2. Do certain fractures cause more sexual dysfunction than others?
3. Can we accurately predict which patients may experience sexual dysfunction post-injury?

Detailed description: Enrollment Visit Following the consent process, patient demographics, injury information, and baseline pre-trauma sexual function will be documented as part of the patient's baseline assessment. Participants will be asked to complete the study survey which will combine 1 question (Item 21 Sexual Dysfunction) from the Disabilities of Arm, Shoulder and Hand (DASH) and the 5 question, Likert-like, Arizona Sexual Experience Scale (ASEX)7,8 . Depending on the participant's response to survey item 1, they may or may not be asked to complete the remaining 5 questions. As part of routine care in the Department of Orthopaedics, patients being seen in the Hand \& Upper Extremity outpatient clinics are asked to complete the following surveys: QuickDASH, SANE, PROMIS Physical Function CAT and PROMIS Anxiety CAT. The study will access/utilize the responses to these routine care patient reported outcomes to correlate to our study survey responses. This routine care PRO data will be stored in the electronic health record. Project team members listed as Key Study Personnel with existing electronic health record (EHR) system access rights may be granted use of REDCap Clinical Data Interoperability Services (CDIS) tools. These tools are designed to enable transfer of relevant study-related data from the Vanderbilt Research Derivative and/or directly from the EHR into REDCap. If KSP are unable to transfer data using CDIS, it will be manually entered into the REDCap database. If, for some reason, the participant does not complete the routine care PROs at their enrollment visit, we will ask them to complete the surveys as part of the study.

Follow-up Visits Participants will be asked to complete the same study survey at their 3 month, 6 month and 12 month follow-up visits. The study will access/utilize the routine care PRO responses (QuickDASH, SANE, PROMIS Physical Function CAT and PROMIS Anxiety CAT) at these visits, also. If, for some reason, the participant does not complete the routine care PROs at their follow-up visit, we will ask them to complete the surveys as part of the study.

If the participant does not have a routine care appointment scheduled at the follow-up visit time points, misses a routine care follow-up appointment or the study staff are not available to collect data at these follow-up appointments, the research coordinator will attempt to contact the patient by phone, mail or electronically using REDCap, to obtain the outcomes data.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (Item 21 Sexual Dysfunction) Score
timeFrame: Change between baseline, 3-month, 6-month, and 12-month visits.
measure: Arizona Sexual Experience Scale (ASEX) Score
timeFrame: Change between baseline, 3-month, 6-month, and 12-month visits.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: